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Study on the Safety and Effectiveness of VIR-2218, VIR-3434, and Peginterferon Alfa-2a for Patients with Chronic Hepatitis B

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for Chronic Hepatitis B Virus Infection, a long-term infection of the liver caused by the hepatitis B virus. The study will explore the safety, tolerability, and effectiveness of different treatment combinations. The treatments being tested include VIR-2218, VIR-3434, and PEG-IFNα. VIR-2218 and VIR-3434 are solutions for injection, with VIR-2218 containing the active substance elebsiran and VIR-3434 containing tobevibart, a type of protein known as a monoclonal antibody. PEG-IFNα, also known as Pegasys, contains the active substance peginterferon alfa-2a and is also administered as an injection.

The purpose of this study is to evaluate how well these treatments work and how safe they are for people with chronic hepatitis B. Participants in the study will receive one or more of these treatments, or a placebo, over a period of up to 48 weeks. The study will monitor participants for any side effects and measure the effectiveness of the treatments in reducing the presence of the virus in the body. The study aims to find out if these treatments can help achieve a functional cure, which means the virus is no longer detectable in the blood and the liver functions normally.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study will also look at how the treatments affect specific markers of the virus in the blood, such as the levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA. The ultimate goal is to find a treatment regimen that is both safe and effective in managing or potentially curing chronic hepatitis B infection.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, physical examination, and laboratory tests to ensure good health apart from chronic hepatitis B virus infection.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. The medications used in this study are Pegasys (peginterferon alfa-2a), Vir-2218 (elebsiran), and Vir-3434 (tobevibart).

    All medications are given as a solution for injection under the skin (subcutaneous).

  3. Step 3

    Medication schedule

    The specific dosage and frequency of each medication are determined based on the study protocol. The duration of administration is aligned with the study's objectives to evaluate safety, tolerability, and efficacy.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes blood tests to measure hepatitis B virus levels and liver function.

    Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is performed. This includes assessing the loss of hepatitis B surface antigen (HBsAg) and any changes in hepatitis B virus DNA levels.

    The study aims to determine the proportion of participants achieving a functional cure, defined as undetectable HBsAg and sustained suppression of hepatitis B virus DNA.

  6. Step 6

    Post-treatment follow-up

    Participants are monitored for 24 weeks after the end of treatment to evaluate the long-term effects and any potential recurrence of the virus.

    The study concludes with a final assessment to determine the overall efficacy and safety of the treatment regimen.

Who can join the trial?

13 criteria

  • Must be between 18 and 65 years old.
  • Body Mass Index (BMI) should be between 18 and 35. BMI is a measure of body fat based on height and weight.
  • Must have **Chronic Hepatitis B Virus Infection**, shown by positive tests for certain markers of the virus at least 6 months apart.
  • Must have been on continuous **NRTI therapy** for at least 2 months before the study. NRTI therapy is a type of treatment for Hepatitis B.
  • **HBV DNA** levels must be less than 100 IU/mL at the start of the study. HBV DNA is a measure of the amount of virus in the blood.
  • **HBsAg** levels must be above the lower limit of detection. HBsAg is a protein on the surface of the Hepatitis B virus.
  • Must test negative for **anti-HBs** at the start of the study. Anti-HBs are antibodies that indicate recovery or immunity from Hepatitis B.
  • Besides having chronic Hepatitis B, must be in good health based on medical history, physical examination, vital signs, and lab tests.
  • Female participants must have a negative pregnancy test or be confirmed as postmenopausal. Postmenopausal means having no menstrual periods for 12 months without another medical reason.
  • Women of childbearing potential must use highly effective birth control methods from 14 days before the study drug is given until 48 weeks after the last dose. They must also agree not to donate eggs or undergo in vitro fertilization during this time.
  • Male participants with female partners who can become pregnant must agree to use certain birth control methods or have a documented vasectomy or azoospermia (no sperm in semen) from the time the study drug is given until 48 weeks after the last dose. They must also agree not to donate sperm during this time.
  • Must be willing to follow the study requirements and able to provide written consent to participate.
  • For a specific group in the study (Cohort 2b), must have been previously enrolled in another part of the study (Cohort 1d) and completed the treatment period.

Who cannot join the trial?

571 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of allergic reactions to similar medications.
  • Using certain medications that might interfere with the study treatment.
  • Having a history of drug or alcohol abuse.
  • Having participated in another clinical trial recently.
  • Having a weakened immune system, which means the body's defense against infections is not strong.
  • Having a history of liver disease other than **Chronic Hepatitis B Virus Infection**.
  • Having a history of cancer within the last five years.
  • Having a history of mental health conditions that are not well controlled.
  • Having a history of heart problems.
  • Having a history of kidney problems.
  • Having a history of blood disorders, which are problems with the blood.
  • Having a history of lung problems.
  • Having a history of gastrointestinal problems, which are issues with the stomach or intestines.
  • Having a history of neurological disorders, which are problems with the brain or nerves.
  • Having a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Having a history of endocrine disorders, which are problems with glands that produce hormones.
  • Having a history of metabolic disorders, which are problems with how the body uses food and energy.
  • Having a history of infectious diseases other than **Chronic Hepatitis B Virus Infection**.
  • Having a history of blood clotting disorders, which are problems with how the blood clots.
  • Having a history of skin disorders that are not well controlled.
  • Having a history of eye disorders that are not well controlled.
  • Having a history of ear disorders that are not well controlled.
  • Having a history of nose or throat disorders that are not well controlled.
  • Having a history of dental problems that are not well controlled.
  • Having a history of musculoskeletal disorders, which are problems with muscles or bones.
  • Having a history of reproductive disorders, which are problems with the reproductive system.
  • Having a history of urinary disorders, which are problems with the bladder or kidneys.
  • Having a history of hematological disorders, which are problems with the blood.
  • Having a history of immunological disorders, which are problems with the immune system.
  • Having a history of genetic disorders, which are inherited conditions.
  • Having a history of congenital disorders, which are conditions present from birth.
  • Having a history of developmental disorders, which are problems with growth or development.
  • Having a history of nutritional disorders, which are problems with diet or nutrition.
  • Having a history of sleep disorders, which are problems with sleeping.
  • Having a history of psychiatric disorders, which are mental health conditions.
  • Having a history of behavioral disorders, which are problems with behavior.
  • Having a history of learning disorders, which are problems with learning.
  • Having a history of speech disorders, which are problems with speaking.
  • Having a history of language disorders, which are problems with understanding or using language.
  • Having a history of communication disorders, which are problems with communication.
  • Having a history of swallowing disorders, which are problems with swallowing.
  • Having a history of feeding disorders, which are problems with eating.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
  • Having a history of dizziness disorders, which are problems with dizziness.
  • Having a history of fainting disorders, which are problems with fainting.
  • Having a history of headache disorders, which are problems with headaches.
  • Having a history of migraine disorders, which are problems with migraines.
  • Having a history of seizure disorders, which are problems with seizures.
  • Having a history of tremor disorders, which are problems with shaking.
  • Having a history of spasm disorders, which are problems with muscle spasms.
  • Having a history of cramp disorders, which are problems with muscle cramps.
  • Having a history of stiffness disorders, which are problems with stiffness.
  • Having a history of rigidity disorders, which are problems with rigidity.
  • Having a history of flexibility disorders, which are problems with flexibility.
  • Having a history of posture disorders, which are problems with posture.
  • Having a history of gait disorders, which are problems with walking.
  • Having a history of coordination disorders, which are problems with coordination.
  • Having a history of balance disorders, which are problems with balance.
  • Having a history of movement disorders, which are problems with movement.
  • Having a history of sensory disorders, which are problems with the senses.
  • Having a history of pain disorders, which are problems with pain.
  • Having a history of fatigue disorders, which are problems with tiredness.
  • Having a history of weakness disorders, which are problems with strength.
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Investigated drugs

  • VIR-2218

    is an investigational medication being studied for its potential to treat chronic Hepatitis B virus infection. It is designed to help reduce the levels of the virus in the body, potentially leading to better management of the infection.

  • VIR-3434

    is another investigational medication included in the study. It is being evaluated for its ability to work alongside other treatments to help control the Hepatitis B virus, aiming to improve the overall effectiveness of the treatment regimen.

  • PEG-IFNα

    (Pegylated Interferon Alpha) is a medication used to treat chronic Hepatitis B. It works by boosting the immune system to fight the virus, helping to reduce the amount of virus in the body and improve liver function.

What is already known about the treatment

  • VIR-2218

    This medication is administered through injection and is currently being studied in clinical trials for its potential to treat chronic Hepatitis B virus infection. It is not yet widely used in medical practice, as it is still under investigation. VIR-2218 works by targeting and reducing the production of viral proteins, which helps to control the infection. It is classified as an antiviral agent.

  • VIR-3434

    Administered via injection, VIR-3434 is also in clinical trials for chronic Hepatitis B virus infection. It is not yet approved for general medical use. The medication functions by binding to the virus, preventing it from entering liver cells and reducing viral load. VIR-3434 is classified as an antiviral agent.

  • PEG-IFNα

    This medication is given by injection and is used in the treatment of chronic Hepatitis B virus infection. It is well-documented in medical literature and is currently used in clinical practice. PEG-IFNα works by enhancing the immune system's response to the virus, helping to control the infection. It is classified as an immunomodulator.

Investigated diseases

Chronic Hepatitis B Virus Infection – This is a long-term infection caused by the hepatitis B virus, which affects the liver. Over time, the virus can lead to liver inflammation, scarring, and potentially liver damage. The infection is often asymptomatic in its early stages, meaning many people may not realize they have it. As the disease progresses, individuals might experience symptoms such as fatigue, jaundice, and abdominal pain. The virus is transmitted through contact with infectious body fluids, such as blood or semen. Chronic infection can persist for years, requiring ongoing monitoring and management to prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513177-48-00Protocol codeVIR-2218-1006Estimated enrolment224 patientsSponsorVir Biotechnology Inc.

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