Not recruitingRare disease

Study on BJT-778 for Patients with Chronic Hepatitis Delta Infection

Fast replyInvestigationalNo 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 a disease called Chronic Hepatitis Delta Infection, which affects the liver. The trial will evaluate a treatment using a medication known as BJT-778, which is given as a solution for injection under the skin. The study will compare the effects of this medication to a delayed treatment approach to see how well it works in managing the infection.

The purpose of the study is to assess the effectiveness of BJT-778 in treating Chronic Hepatitis Delta Infection over a period of time. Participants in the study will receive either the medication or a delayed treatment and will be monitored to see how their condition changes. The study will look at various outcomes, including changes in the levels of the virus in the body and improvements in liver function.

The trial will take place over several weeks, with participants being checked at different points to see how they are responding to the treatment. The study aims to provide valuable information on whether BJT-778 can be an effective treatment option for people with Chronic Hepatitis Delta Infection.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide written informed consent, confirming your willingness to participate and understanding of the trial procedures.
You must be at least 18 years old and have a confirmed diagnosis of chronic hepatitis delta infection, which means you have tested positive for the virus for at least six months.
Step 2
Initial screening
During the initial screening, your health will be assessed to ensure you meet the trial's requirements. This includes a blood test to check the level of the virus in your body, which must be above 500 IU/mL.
Your liver function will also be evaluated by measuring a specific enzyme called ALT. This enzyme level must be above the normal range.
Step 3
Baseline treatment
You will need to be taking or be willing to start taking one of the following medications: tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV).
These medications help manage your condition and you must continue taking them consistently throughout the trial.
Step 4
Treatment with BJT-778
You will receive a medication called BJT-778, which is administered as a solution for injection under the skin, known as a subcutaneous injection.
The frequency and dosage of this medication will be determined by the trial team and will continue for the duration of the study.
Step 5
Regular assessments
Throughout the trial, your health will be monitored regularly. This includes checking the level of the virus in your blood and the function of your liver.
These assessments will occur at specific intervals, such as weeks 24, 48, and 96, to evaluate the effectiveness of the treatment.
Step 6
Safety monitoring
Your safety is a priority, and any side effects or adverse reactions to the treatment will be closely monitored.
If any severe side effects occur, the trial team may decide to adjust your treatment or discontinue it if necessary.
Step 7
End of trial
The trial is expected to continue until June 2029, but your participation may end earlier depending on your health and the trial's progress.
At the end of your participation, a final assessment will be conducted to evaluate your overall health and the impact of the treatment.

Who can join the trial?

6 criteria

Willing and able to provide written informed consent. This means you agree to participate in the study and understand what it involves.
Must be a male or female who is at least 18 years old at the time of the screening.
Must have a confirmed chronic Hepatitis Delta Virus (HDV) infection. This means you have tested positive for the virus for at least 6 months before the study starts.
Must have an HDV RNA level greater than 500 IU/mL at the time of screening. This is a measure of the amount of virus in your blood.
Must have an ALT level above the normal limit at the time of screening. ALT is a liver enzyme, and higher levels can indicate liver inflammation.
Must be taking or willing to take one of the following medications: tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV) at the start of the study, and agree to continue this treatment throughout the study. These are medications used to treat viral infections.

Who cannot join the trial?

5 criteria

Patients with any other type of **hepatitis** infection besides **Chronic Hepatitis Delta** cannot participate. **Hepatitis** is a disease that affects the liver.
Patients who are not within the age range specified for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have any other medical condition that might interfere with the study results cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Verified
Sliven, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

BJT-778
is a medication being tested in this clinical trial for its effectiveness in treating chronic hepatitis delta infection. It is being compared to a delayed treatment approach to see if it can help manage the infection more effectively. The trial aims to understand how well BJT-778 works in improving the health of patients with this condition.
Brelovitug
is another medication involved in this trial. It is being evaluated to see how effective it is in treating chronic hepatitis delta infection over a period of 24 weeks. The goal is to determine if brelovitug can provide better outcomes for patients compared to waiting to start treatment later.

Bjt-778

What is already known about the treatment

Brelovitug – Brelovitug is administered as an injection, typically given under the skin, to treat chronic hepatitis delta infection. It is currently being studied in clinical trials to determine its effectiveness and safety for this condition. The main therapeutic use of brelovitug is to help manage chronic hepatitis delta, a severe liver infection. At the molecular level, brelovitug works by targeting specific proteins involved in the virus's ability to replicate, thereby reducing the viral load in the body. It is classified as an antiviral medication, specifically designed to combat viral infections like hepatitis delta.

Investigated diseases

Chronic Hepatitis Delta Infection – This disease is a liver infection caused by the hepatitis delta virus (HDV), which requires the presence of hepatitis B virus (HBV) to replicate. It is characterized by inflammation of the liver, which can lead to liver damage over time. The infection progresses as the virus continues to replicate, causing ongoing liver inflammation and damage. Over time, this can result in fibrosis, where scar tissue forms in the liver, and potentially cirrhosis, which is severe scarring that affects liver function. The disease can also lead to an increase in liver enzymes, such as alanine aminotransferase (ALT), indicating liver inflammation or damage. Chronic Hepatitis Delta Infection is considered a rare disease and can significantly impact liver health over time.