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Study of Tenofovir Alafenamide for Children and Teens with Chronic Hepatitis B

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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 the effects of a medication called Tenofovir Alafenamide (also known by its code name GS-7340) in children and teenagers who have a condition known as Chronic Hepatitis B. Chronic Hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. The study aims to understand how safe and effective Tenofovir Alafenamide is in treating this condition in young people.

The study involves two groups of participants. The first group includes teenagers aged 12 to under 18 years, and the second group includes children aged 2 to under 12 years. Participants in both groups will receive either Tenofovir Alafenamide or a placebo once a day. The study will last for several weeks, during which the safety and effectiveness of the medication will be closely monitored. The goal is to see if the medication can reduce the amount of hepatitis B virus in the body and improve liver health.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects they might experience. The study will also look at how the medication is processed in the body, which is known as pharmacokinetics. This information will help determine the best dose for treating Chronic Hepatitis B in children and teenagers. The study is expected to continue for several years to gather comprehensive data on the long-term effects of the treatment.

The research process

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

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a detailed medical history is taken, and a physical examination is conducted to ensure eligibility for the trial.
Blood samples are collected to confirm the presence of chronic hepatitis B virus infection and to assess liver function.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication, tenofovir alafenamide (TAF), or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Medication administration
For adolescents aged 12 to less than 18 years and weighing at least 35 kg, the dosage is 25 mg of TAF once daily.
For children aged 2 to less than 12 years, the dosage is determined based on weight, with TAF administered once daily.
The medication is taken orally, either as granules or film-coated tablets, depending on the participant's age and weight.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor health and response to the medication. These visits occur at weeks 4, 8, 12, and 24, with additional visits at weeks 48, 96, and 240.
During these visits, blood samples are collected to measure the level of hepatitis B virus in the blood and to check liver function.
Step 5
Safety and efficacy evaluation
The primary goal is to evaluate the safety and effectiveness of TAF in reducing the hepatitis B virus to undetectable levels in the blood by week 24.
Participants are monitored for any side effects or adverse events throughout the study duration.
Step 6
Long-term monitoring
Participants continue to be monitored for up to 240 weeks to assess long-term safety and the continued effectiveness of the treatment.
Additional assessments include bone mineral density and kidney function tests at specified intervals.

Who can join the trial?

13 criteria

Age: Must be between 2 and 17 years old.
Gender: Open to both males and females, but females must not be pregnant or breastfeeding.
Weight:
- Cohort 1: Must weigh at least 35 kg (about 77 lbs).
- Cohort 2 Group 1: Must weigh at least 25 kg (about 55 lbs).
- Cohort 2 Group 2: Must weigh between 14 kg and 25 kg (about 30 lbs to 55 lbs).
- Cohort 2 Group 3: Must weigh between 10 kg and 14 kg (about 22 lbs to 30 lbs) or between 14 kg and 25 kg (about 30 lbs to 55 lbs).
- Consent: Must be willing and able to provide written consent or assent. This means both the child and their parent or legal guardian agree to participate.
- Medical Condition: Must have documented evidence of Chronic Hepatitis B (CHB). This includes being positive for a specific marker called HBsAg for at least 6 months.
- HBV Infection: Must have either HBeAg-positive or HBeAg-negative chronic HBV infection with:
  - HBV DNA level of at least 20,000 IU/mL at screening.
  - Serum ALT level greater than 45 U/L but less than or equal to 10 times the upper limit of normal.
  - Treatment History: Can be either new to treatment or have previous treatment experience.
  - Kidney Function: Must have an estimated creatinine clearance (a measure of kidney function) of at least 80 mL/min/1.73m², calculated using the Schwartz formula.
  - Heart Health: Must have a normal ECG (a test that checks for problems with the electrical activity of the heart).

Who cannot join the trial?

8 criteria

Patients who are not diagnosed with Chronic Hepatitis B cannot participate.
Patients who are younger than 2 years old or older than 18 years old cannot participate.
Patients who weigh less than 35 kg cannot participate.
Patients who are not able to take the study medication as prescribed cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.

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Verified sites

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Spitalul Clinic De Urgenta Pentru Copii Grigore Alexandrescu
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Bucharest, Romania

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Investigated drugs

Tenofovir Alafenamide (TAF) is a medication used in this clinical trial to treat children and adolescents with chronic hepatitis B virus infection. It works by reducing the amount of hepatitis B virus in the body, which helps the immune system fight the infection and can improve liver function. The trial aims to evaluate how safe and effective this medication is for young patients, as well as how well their bodies process it. Participants in the trial will take TAF once a day, and researchers will monitor its impact on the virus levels in their blood and any side effects they might experience.

Tenofovir Alafenamide

What is already known about the treatment

Tenofovir Alafenamide (TAF) – Tenofovir Alafenamide is administered orally in the form of a tablet and is currently being studied for its effectiveness and safety in treating chronic Hepatitis B, particularly in children and adolescents. This medication is designed to reduce the amount of hepatitis B virus in the body, helping to manage the infection. At the molecular level, TAF works by inhibiting the virus's ability to replicate its DNA, which is crucial for its survival and multiplication. It belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors, which are commonly used in antiviral therapies.

Investigated diseases

Chronic Hepatitis B – Chronic Hepatitis B is a long-lasting infection caused by the hepatitis B virus (HBV) that affects the liver. The disease begins with the virus entering the body and targeting liver cells, leading to inflammation. Over time, the persistent infection can cause liver damage as the immune system attacks infected cells. This ongoing liver inflammation can result in scarring, known as fibrosis, and may progress to more severe liver damage. The disease can remain asymptomatic for years, but some individuals may experience symptoms like fatigue, jaundice, and abdominal pain. The progression of the disease varies, with some individuals experiencing slow progression while others may develop significant liver damage more quickly.