RecruitingRare disease

Study on the Effects and Safety of Bulevirtide, Peginterferon Alfa-2a, and Entecavir in Patients with Chronic Hepatitis D

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 the treatment of chronic hepatitis D, a liver infection caused by the hepatitis D virus. The treatment being evaluated is called Bulevirtide, which is administered as a solution for injection. The purpose of the study is to assess the effectiveness and safety of Bulevirtide in patients with chronic hepatitis D.

Participants in the study will receive Bulevirtide and will be monitored over a period of time to observe their response to the treatment. The study will track the levels of the virus in the blood and other health markers to determine how well the treatment works. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Bulevirtide. The study aims to see if the virus levels become undetectable in the blood after treatment and to monitor any changes in liver health and overall well-being.

The study will involve regular check-ups and tests to ensure the safety of the participants and to gather data on the treatment's impact. The results will help understand the potential benefits and risks of using Bulevirtide for treating chronic hepatitis D. This information could be valuable for developing future treatment options for this condition.

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 visit
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood samples are collected to assess liver function and viral load. This helps in establishing a baseline for future comparisons.
Step 2
Treatment initiation
The treatment begins with the administration of bulevirtide through a subcutaneous injection. This is a solution injected under the skin.
The dosage is determined by the healthcare provider and is typically administered once daily.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled every three months during the treatment period. These visits include blood tests to monitor the viral load and liver function.
The healthcare provider assesses the response to treatment and any side effects experienced.
Step 4
End of treatment
The treatment period concludes as determined by the healthcare provider, based on the patient's response and overall health.
A comprehensive evaluation is conducted to assess the effectiveness of the treatment.
Step 5
Follow-up period
After the end of treatment, follow-up visits are scheduled at 3, 6, 9, and 12 months to monitor the patient's health and any long-term effects of the treatment.
These visits include blood tests and assessments of liver function and viral load.

Who can join the trial?

10 criteria

Must be over 18 years old.
Must have a diagnosis of chronic HBV/HDV co-infection (this means having both hepatitis B and hepatitis D viruses).
Must have compensated liver disease (this means the liver is damaged but still able to function well enough, even if there are signs of portal hypertension, which is increased blood pressure in the vein that carries blood to the liver).
Must need treatment with BLV (a specific medication) or already be receiving it.
For female participants:
- Must be postmenopausal for at least one year, or
- Must be surgically sterile (such as having had a total hysterectomy or removal of ovaries), or
- Must abstain from heterosexual intercourse during the treatment period, or
- Must be willing to use highly effective contraception (such as using two methods of birth control together) during the treatment period and for 6 months after the last dose of the study drugs.
- Male participants must agree to use highly effective contraception (such as using two methods of birth control together) during the treatment period and for 6 months after the last dose of the study drugs.
- Must be willing to give written informed consent (this means agreeing to participate in the study after being fully informed about it).

Who cannot join the trial?

1 criterion

Patients with **hepatitis D** cannot participate. Hepatitis D is a liver infection caused by the hepatitis D virus.

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Verified sites

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Verified
Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Bulevirtide is a medication used in this clinical trial to treat patients with chronic hepatitis D. It works by blocking the entry of the hepatitis D virus into liver cells, which helps to reduce the amount of virus in the body. The goal of using Bulevirtide in this study is to see if it can effectively lower the virus levels to a point where they are undetectable, and to evaluate its safety and the changes it causes in certain biological markers over time.

What is already known about the treatment

Bulevirtide – Bulevirtide is administered as an injection under the skin, typically in the abdomen or thigh. It is currently being studied in clinical trials for its effectiveness and safety in treating chronic hepatitis D, a liver infection caused by the hepatitis D virus. The main therapeutic use of Bulevirtide is to help reduce the amount of virus in the body, aiming for a virological response where the virus is undetectable. At the molecular level, Bulevirtide works by blocking the entry of the virus into liver cells, preventing it from multiplying. It is classified as an antiviral medication.

Investigated diseases

Hepatitis D – Hepatitis D is a liver infection caused by the hepatitis D virus (HDV), which requires the presence of hepatitis B virus (HBV) to replicate. The disease begins with the entry of HDV into liver cells, where it uses the machinery of HBV to multiply. Initially, individuals may experience symptoms such as fatigue, jaundice, and abdominal pain. As the infection progresses, it can lead to inflammation and damage to liver cells. Over time, this can result in liver fibrosis, where scar tissue forms in the liver, potentially leading to cirrhosis. The progression of hepatitis D is often more severe than hepatitis B alone, due to the additional viral burden and immune response.