Study on BJT-778 for Patients with Chronic Hepatitis B and D Infections

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called BJT-778 on individuals with Chronic Hepatitis B Infection and Chronic Hepatitis D Infection. Hepatitis B and Hepatitis D are liver infections caused by viruses, which can lead to serious liver damage over time. The study aims to evaluate the safety and tolerability of BJT-778, which is administered as a solution for injection under the skin. Some participants will receive a placebo for comparison.

The study will begin with healthy volunteers to assess the initial safety of BJT-778. Following this, individuals with Chronic Hepatitis B and Chronic Hepatitis D will participate to further evaluate the treatment’s effects. Participants will receive injections and be monitored for any side effects or changes in their health. The study will also measure how the body processes the drug and its impact on the viruses causing the infections.

Throughout the study, researchers will collect data on the participants’ health and any changes in their condition. This information will help determine the potential benefits and risks of BJT-778 for treating these chronic liver infections. The study is expected to continue until early 2025, providing valuable insights into the treatment’s effectiveness and safety.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will provide written informed consent, confirming your understanding and willingness to participate in the trial.

Your medical history will be reviewed, and you will undergo a physical examination. Blood samples will be taken to confirm eligibility based on specific health criteria.

2 randomization

After eligibility is confirmed, you will be randomly assigned to receive either the study medication BJT-778 or a placebo. This process is called randomization and ensures that the study results are unbiased.

3 treatment phase

During the treatment phase, you will receive the study medication BJT-778 or placebo. The medication is administered as a solution for injection.

The injections will be given either intravenously (into a vein) or subcutaneously (under the skin), depending on the specific requirements of the study.

4 regular follow-up visits

You will attend regular follow-up visits throughout the study. These visits are scheduled to monitor your health and the effects of the medication.

During these visits, you will undergo physical examinations, and blood samples will be collected to assess your response to the treatment.

5 end of treatment

At the end of the treatment phase, you will have a final visit. This visit will include a comprehensive health assessment to evaluate the overall impact of the study medication.

You will be asked to continue using an acceptable contraceptive method for at least 12 weeks after the last dose of the study drug, if applicable.

6 post-study follow-up

After completing the treatment phase, you may be asked to attend additional follow-up visits. These visits are designed to monitor your health after the study medication has been discontinued.

The study team will provide specific instructions regarding any additional follow-up requirements.

Who Can Join the Study?

Able and willing to provide written informed consent, which means you agree to participate in the study and understand what it involves.
Must be a male or female adult between 18 and 70 years of age.
Have a Body Mass Index (BMI) between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Have a chronic Hepatitis B virus (HBV) infection for at least 6 months. This means you have tested positive for the virus for 6 months or more.
Have a plasma HBV DNA level of less than 100 IU/mL at screening. This is a measure of the amount of virus in your blood.
Currently taking certain medications for HBV (entecavir, tenofovir disoproxil, or tenofovir alafenamide) for at least 2 months and willing to continue this treatment during the study.
Meet specific HBsAg level criteria at screening, which varies by group in the study. HBsAg is a protein on the surface of the Hepatitis B virus.
For females: Must be nonpregnant and nonlactating. If of childbearing potential, must use an acceptable contraceptive method during the study and for at least 12 weeks after the last dose of the study drug.
For males: Must be surgically sterile or use an acceptable contraceptive method if engaging in sexual relations with a female of childbearing potential during the study and for at least 12 weeks after the last dose of the study drug. Must agree not to donate sperm for at least 12 weeks after the last dose of the study drug.

Who Cannot Join the Study?

Patients with Chronic Hepatitis B Infection cannot participate. This is a long-lasting infection of the liver caused by the hepatitis B virus.
Patients with Chronic Hepatitis D Infection cannot participate. This is a long-lasting infection of the liver caused by the hepatitis D virus.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania
Hopital Beaujon	Clichy	France
Multispecialty hospital for active treatment Sveta Sofia EOOD	Sofia	Bulgaria
Cfo Chvxx Rjirjvqekea	Lyon	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.06.2023
France	Not recruiting	01.06.2023
Romania	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

BJT-778 is a new medication being tested to see if it is safe and well-tolerated by people. It is being studied in healthy volunteers and in people who have chronic hepatitis B and D infections. The goal is to understand how the body processes this medication and to see if it can help fight the viruses that cause these infections. This study is in its early stages, so researchers are primarily focused on making sure the medication does not cause any harmful effects and to learn more about how it works in the body.

Investigated diseases:

Chronic hepatitis B

Chronic Hepatitis B Infection – This is a long-lasting infection of the liver caused by the hepatitis B virus. The virus can remain in the body for a long time, leading to ongoing inflammation of the liver. Over time, this inflammation can cause liver damage, including scarring known as fibrosis. As the disease progresses, it may lead to more severe liver damage, such as cirrhosis, where the liver becomes severely scarred and its function is impaired. The infection can also increase the risk of developing liver cancer. The disease is primarily spread through contact with infectious body fluids, such as blood.

Chronic Hepatitis D Infection – This is a liver infection caused by the hepatitis D virus, which can only occur in individuals who are already infected with the hepatitis B virus. The presence of both viruses can lead to more severe liver disease compared to infection with hepatitis B alone. The disease causes inflammation of the liver, which can progress to liver damage over time. This damage can result in fibrosis, cirrhosis, and potentially liver failure. The infection is primarily spread through contact with infected blood. The progression of the disease can vary, but it often leads to more rapid liver damage than hepatitis B infection alone.

Trial ID:

2022-502724-46-00

Protocol code:

BJT-778-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on BJT-778 for Patients with Chronic Hepatitis B and D Infections

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