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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD	Sliven	Bulgaria

Other Sites

Site Name	City	Country	Status
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	02.06.2025

Trial locations

Investigated drugs:

Bjt-778

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.

Investigated diseases:

Hepatitis D

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.

Trial ID:

2024-519063-18-00

Protocol code:

BJT-778-301

Trial Phase:

Therapeutic use (Phase IV)

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

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