Not recruiting

Study on the Effectiveness of Human Hepatitis B Immunoglobulin for Patients with Chronic Hepatitis B

Verified siteRegistered 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 chronic hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The study aims to evaluate the effectiveness of a treatment using specific immune antibodies known as hepatitis B immunoglobulins. These antibodies are designed to help the body fight the virus and potentially clear the infection. Two different forms of the treatment are being tested: Hepatect CP, which is given as an infusion directly into the bloodstream, and Zutectra, which is administered as an injection under the skin.

The purpose of the study is to assess how well these treatments work in helping patients with chronic hepatitis B become free of the virus. Participants will receive the treatment for a period of 12 weeks. During this time, the study will monitor the presence of the virus in the blood and any changes in liver health. The study will also look at the quality of life of participants during and after the treatment period.

Participants will be divided into two groups, or cohorts, based on their previous treatment history and current health status. The study will track the progress of the virus in each group, with a focus on whether the virus is no longer detectable in the blood by the end of the 12-week treatment. The study will also observe any changes in liver function and overall well-being during the treatment and follow-up period.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and previous treatment history.
A written informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to document the current health status, including a negative serum pregnancy test for female participants, if applicable.
Confirmation of chronic hepatitis B infection is required, with specific criteria for different patient cohorts.
Step 3
Treatment phase
The treatment involves the administration of hepatitis B immunoglobulins over a period of 12 weeks.
Two medications are used: Hepatect CP (administered via intravenous infusion) and Zutectra (administered via subcutaneous injection).
The goal is to evaluate the effectiveness of the treatment in achieving HBsAg negativity by week 12.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the decline in HBsAg levels at weeks 1, 2, 4, 8, and 12.
Additional assessments include monitoring HBV DNA levels and biochemical responses, such as ALT normalization.
Step 5
Follow-up phase
Post-treatment follow-up extends up to 24 weeks to monitor HBsAg negativity and overall health status.
Quality of life is assessed during the treatment and follow-up periods using standardized questionnaires.

Who can join the trial?

11 criteria

Willing and able to provide written informed consent.
For female participants, a negative pregnancy test is required unless they are surgically sterile or over 54 years old and have not had a period for more than 24 months. They must agree to complete abstinence from intercourse or use reliable birth control methods, such as an intrauterine device (IUD), bilateral tubal sterilization, a partner with a vasectomy, or hormone-containing contraceptives.
Must be able to follow the instructions for taking the study medication and complete the study schedule.
Must be male or female and at least 18 years old.
Must have a confirmed chronic hepatitis B infection, shown by a positive test for the hepatitis B surface antigen (HBsAg) at least 12 months before the study starts.
For Cohort A: Must have been treated with nucleos(t)ide analogues (NA) for at least 12 months before the study starts. The hepatitis B virus (HBV) DNA should be below the detectable level at the start of the study. Must be HBsAg positive and less than 100 IU/ml, and HBeAg negative.
For Cohort B: Must not have been treated with NAs for at least 12 months before the study starts. The HBV DNA should be less than 2000 IU/ml. Must be HBsAg positive and less than 100 IU/ml, and HBeAg negative.
Must not have been treated with any investigational drug or device within 42 days before the study starts or within 5 half-lives of the investigational drug, whichever is longer.
Must have a Transient Elastography (FibroScan) result of less than 7.5 kPa at the start of the study. This test measures liver stiffness.
Must have alanine aminotransferase (ALT) levels less than 1.5 times the upper limit of normal at the start of the study. ALT is an enzyme that helps assess liver health.
Must have a body mass index (BMI) greater than 18 kg/m². BMI is a measure of body fat based on height and weight.

Who cannot join the trial?

3 criteria

Patients who do not have chronic hepatitis B cannot participate. Chronic hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.

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Medizinische Hochschule Hannover
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Hanover, Germany

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Investigated drugs

Hepatitis B Immunoglobulins are used in this clinical trial to help clear the hepatitis B surface antigen (HBsAg) in patients with chronic hepatitis B. The goal is to see if a 12-week treatment can effectively reduce the presence of HBsAg in the blood, which is a marker of active hepatitis B infection. This therapy involves using antibodies specifically designed to target and neutralize the hepatitis B virus, potentially leading to a cure or significant improvement in the condition.

Human Hepatitis B Immunoglobulin

What is already known about the treatment

Hepatitis B Immunoglobulins – This medication is administered through an injection, typically given in a healthcare setting. It is currently being studied in clinical trials to assess its effectiveness in treating chronic hepatitis B. The main therapeutic indication is to help clear the hepatitis B surface antigen (HBsAg) in patients with chronic hepatitis B. At the molecular level, it works by providing antibodies that target and neutralize the hepatitis B virus, aiding the immune system in clearing the infection. It is classified as an immunoglobulin, which is a type of antibody used to boost the body's immune response.

Investigated diseases

Chronic Hepatitis B – This is a long-lasting infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to liver cells over time. The disease progresses slowly, often without noticeable symptoms in the early stages. As it advances, individuals may experience fatigue, jaundice, and abdominal discomfort. Chronic hepatitis B can result in liver scarring and, in some cases, liver failure if not managed. The virus is primarily spread through contact with infectious body fluids.