Study on the Effects of Peginterferon Alfa-2a, Tobevibart, and Elebsiran in Patients with Chronic Hepatitis B Infection

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What is this study about?

This clinical trial is focused on studying treatments for Chronic Hepatitis B Virus (HBV) Infection. The study will evaluate the effectiveness and safety of several investigational therapies. The treatments being tested include Pegasys, which is a solution for injection containing the active substance peginterferon alfa-2a, Vir-3434 with the active substance tobevibart, Vir-2218 containing elebsiran, and Viread, which is a film-coated tablet with the active substance tenofovir disoproxil. Some participants may receive a placebo during the study.

The purpose of the study is to evaluate how well these treatments work in managing chronic HBV infection. Participants will receive the treatments over a period of time, with regular monitoring to assess the effects. The study will involve injections and oral tablets, depending on the specific treatment being tested. Participants will be monitored for changes in their health and any side effects that may occur during the study.

The study aims to determine if the treatments can effectively reduce the levels of the virus in the body and improve the health of those with chronic HBV infection. The results will help in understanding the potential benefits and risks of these investigational therapies for managing the disease. Participants will be closely observed throughout the study to ensure their safety and to gather important data on the treatments’ effectiveness.

1 initial visit

Upon joining the study, an initial visit is conducted to confirm eligibility. This involves a review of medical history and a physical examination. Blood tests are performed to confirm chronic hepatitis B infection and assess overall health.

Female participants undergo a pregnancy test to ensure they are not pregnant. Male participants are informed about contraception requirements.

2 treatment phase

The treatment phase begins with the administration of investigational therapies. The medications used include peginterferon alfa-2a, tobevibart, and elebsiran, which are given as subcutaneous injections. Tenofovir disoproxil is taken orally in the form of a 245 mg film-coated tablet.

The frequency and duration of administration are determined by the study protocol. Participants are monitored regularly to assess the effectiveness and safety of the treatment.

3 monitoring and follow-up

Throughout the study, regular follow-up visits are scheduled to monitor health status and response to treatment. Blood tests are conducted to measure levels of hepatitis B virus and other relevant markers.

Participants are observed for any side effects or adverse reactions to the medications. Adjustments to the treatment regimen may be made based on these observations.

4 end of treatment

At the end of the treatment phase, a comprehensive evaluation is performed. This includes blood tests to assess the suppression of the hepatitis B virus and the loss of specific virus markers.

Participants are informed about the results and any further steps required for their health management.

5 post-treatment follow-up

A follow-up period of 24 weeks is conducted after the discontinuation of all treatments. During this time, participants attend scheduled visits to monitor the sustained suppression of the virus.

The final assessment includes a review of the overall health status and any long-term effects of the treatment.

Who Can Join the Study?

Must be an adult who is 18 years or older.
Must have chronic Hepatitis B virus (HBV) infection. This means having a positive test for HBV on two occasions at least 6 months apart.
Must be in good health apart from the HBV infection, as determined by medical history and physical examination.
Female participants must have a negative pregnancy test or be confirmed as postmenopausal, which means not having a menstrual period for 12 months without another medical reason. They must not be breastfeeding and must agree to use effective birth control methods.
Male participants with female partners who can become pregnant must agree to use birth control methods or have had a vasectomy (a procedure to prevent sperm from being part of the semen) or have no sperm in their semen (azoospermia). They must also agree not to donate sperm during the study.
Must be able to understand and follow the study requirements and provide written consent to participate.

Who Cannot Join the Study?

Patients with other types of liver disease besides Chronic Hepatitis B Virus (HBV) Infection cannot participate.
Patients who have had a liver transplant are not eligible.
Patients with a history of liver cancer cannot join the study.
Patients who are currently pregnant or breastfeeding are excluded.
Patients with severe kidney problems are not allowed to participate.
Patients who have a history of alcohol or drug abuse in the past year cannot take part.
Patients who are currently participating in another clinical trial are not eligible.
Patients with any other serious medical condition that might interfere with the study are excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
France	Not recruiting	29.11.2022
Romania	Not recruiting	29.11.2022

Trial locations

Investigated drugs:

Investigational Therapy A is a new treatment being tested to see if it can help people with chronic hepatitis B infection. This therapy is not yet available to the public and is being studied to understand how well it works and how safe it is for patients. The goal is to see if it can reduce the amount of the virus in the body and improve liver health.

Investigational Therapy B is another new treatment option being explored in this study for chronic hepatitis B. Like Therapy A, it is being tested to determine its effectiveness in lowering the virus levels and its safety for patients. Researchers are looking to see if this therapy can offer a new way to manage hepatitis B and improve patient outcomes.

Investigated diseases:

Chronic hepatitis B

Chronic Hepatitis B Virus (HBV) Infection – This disease is a long-term infection caused by the hepatitis B virus, which affects the liver. It begins with the virus entering the body and targeting liver cells, leading to inflammation. Over time, the infection can cause liver damage as the immune system attacks infected cells. The disease progresses slowly, often over many years, and can lead to liver scarring, known as fibrosis. In some cases, the liver may become severely scarred, a condition called cirrhosis. The infection can remain active in the body, causing ongoing liver inflammation and damage.

Trial ID:

2024-513176-17-00

Protocol code:

VIR-MHB1-V200

NCT ID:

NCT05612581

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Peginterferon Alfa-2a, Tobevibart, and Elebsiran in Patients with Chronic Hepatitis B Infection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?