Not recruiting

Study on the Effectiveness and Safety of JNJ-73763989 and Tenofovir Alafenamide in Patients with Hepatitis B and D Co-infection

Fast replyRegistered 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 the treatment of people who are co-infected with Hepatitis B and Hepatitis D viruses. The study will use a combination of a new treatment called JNJ-73763989 and a type of medication known as a nucleos(t)ide analog. These medications are being tested to see how well they work together in treating the infections.

The purpose of the study is to evaluate the effectiveness and safety of the treatment combination. Participants in the study will receive either the new treatment with the nucleos(t)ide analog or a placebo. The study will be conducted over a period of time, during which participants will be monitored for changes in their health and the levels of the viruses in their bodies. The study aims to see if the combination treatment can reduce the amount of the Hepatitis D virus in the body and improve liver health.

Throughout the study, participants will have regular check-ups and tests to track their progress. The study is designed to provide valuable information about the potential benefits of the new treatment for people with these viral infections. The results will help determine if this combination of medications can be a safe and effective option for managing Hepatitis B and Hepatitis D co-infections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a physical examination, review of medical history, and vital signs check.
A 12-lead ECG is performed to assess heart function. Blood tests are conducted to confirm chronic hepatitis B and D infections.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either the study medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The study medication includes JNJ-73763989 administered via subcutaneous injection, combined with a nucleos(t)ide analog taken orally.
Step 3
Treatment phase
Participants receive the assigned treatment for a specified duration. The JNJ-73763989 is given as a solution for injection, while the nucleos(t)ide analog is taken orally.
Regular follow-up visits are scheduled to monitor health status, medication adherence, and any side effects.
Step 4
Efficacy and safety evaluation
Throughout the study, the efficacy of the treatment is evaluated by measuring the decline in hepatitis D virus (HDV) RNA levels and monitoring liver enzyme levels.
Safety assessments are conducted regularly to ensure the well-being of participants.
Step 5
End of treatment and follow-up
At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.
Participants may be asked to return for follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

7 criteria

The participant can be a male or female, based on their biological characteristics.
Participants must be between 18 and 65 years old. If the legal age of consent is higher than 18 in the study area, participants must meet that age requirement.
Participants should be in a medically stable condition, which means their health is generally good based on a physical exam, medical history, vital signs, and a heart test called a 12-lead ECG.
Participants must have a chronic hepatitis B infection, which means they have had the infection for a long time. This can be either HBeAg positive or negative, and they may or may not be receiving NA treatment. This infection is confirmed by a positive test for a substance called HBsAg in their blood.
Participants must also have a chronic hepatitis D infection, confirmed by a positive test for HDV antibodies or HDV RNA in their blood.
For Part 1 of the study, participants must have HDV RNA levels of at least 1,000 IU/mL in their blood at the start of the study.
For Part 2 of the study, participants must have HDV RNA levels of at least 500 IU/mL and HBsAg levels of no more than 10,000 IU/mL in their blood at the start of the study.

Who cannot join the trial?

5 criteria

Patients who have a different type of liver infection other than Hepatitis B and Hepatitis D.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

JNJ-3989
is an investigational medication being studied for its potential to treat individuals co-infected with Hepatitis B and Hepatitis D viruses. It is being evaluated for its ability to reduce the levels of the Hepatitis D virus in the body when used in combination with another type of medication.
Nucleos(t)ide Analog
is a type of medication commonly used to treat Hepatitis B infection. In this study, it is used to help control the Hepatitis B virus, and its effects are being compared when used alone versus in combination with JNJ-3989.

What is already known about the treatment

JNJ-3989 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating co-infections of Hepatitis B and Hepatitis D. It is in the experimental phase and not yet widely available in medical practice. The main therapeutic indication is for patients with Hepatitis B and Hepatitis D viral co-infection. JNJ-3989 works by targeting and reducing the production of viral proteins, thereby inhibiting the replication of the virus at the molecular level. It is classified pharmacologically as an antiviral agent.

Investigated diseases

Hepatitis B and Hepatitis D Viral Co-infection – This condition occurs when a person is infected with both the Hepatitis B virus (HBV) and the Hepatitis D virus (HDV). Hepatitis B is a liver infection caused by the HBV, which can lead to liver inflammation, damage, and scarring. Hepatitis D, also known as delta hepatitis, is a liver infection caused by the HDV, which can only infect individuals who are already infected with HBV. The co-infection can result in more severe liver disease compared to infection with HBV alone. Over time, this co-infection can lead to chronic liver disease, increasing the risk of liver cirrhosis and liver failure. The progression of the disease can vary, with some individuals experiencing rapid liver damage while others may have a slower progression.