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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	22.05.2023

Trial locations

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.

Investigated diseases:

Hepatitis D

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.

Trial ID:

2023-504414-29-00

Protocol code:

SEE-D

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

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