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Study on Bulevirtide Treatment for 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 effects of a treatment for Chronic Hepatitis D Infection, a liver disease caused by the hepatitis D virus. The treatment being studied is called Bulevirtide, which is administered as a powder that is mixed into a solution for injection. The purpose of the study is to observe the long-term effects of Bulevirtide on the progression of liver disease in individuals with chronic hepatitis D.

Participants in the study will receive Bulevirtide over a period of time, and researchers will monitor them for any liver-related events, such as liver failure, liver cancer, or the need for a liver transplant. The study will also track the percentage of participants who develop cirrhosis, a condition where the liver becomes severely scarred, and any serious side effects that may occur during the treatment.

The study aims to provide valuable information on how Bulevirtide affects the health of people with chronic hepatitis D over an extended period. This information could help improve treatment options for those living with this condition. Participants will be observed for up to 144 weeks to gather comprehensive data on the treatment's impact.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participants will be required to sign a written informed consent form. This form confirms understanding of the study and agreement to participate.

    Participants must be at least 18 years old and have been diagnosed with chronic hepatitis D infection for at least six months prior to joining the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's health status. This includes checking for conditions such as ascites (fluid in the abdomen) and hepatic encephalopathy (a decline in brain function due to liver disease).

    Laboratory tests will be performed to measure levels of serum bilirubin, serum creatinine, international normalized ratio (INR), and serum albumin. These tests help calculate scores that assess liver function.

  3. Step 3

    Treatment initiation

    Participants will begin treatment with bulevirtide, administered as a solution for injection under the skin (subcutaneous use).

    The dosage is 2 mg of bulevirtide, and the frequency and duration of administration will be determined according to the approved treatment plan.

  4. Step 4

    Ongoing monitoring

    Participants will attend regular visits to monitor their health and the effects of the treatment. This includes checking for any liver-related events such as hepatic decompensation, hepatocellular carcinoma, or other serious conditions.

    The study will track the percentage of participants who develop cirrhosis and any serious adverse events that occur during the treatment period.

  5. Step 5

    Completion of study

    The study is expected to continue until September 30, 2027. Participants will be involved in the study for up to 144 weeks, depending on their individual treatment plan.

    At the end of the study, a final assessment will be conducted to evaluate the long-term effects of bulevirtide treatment on liver disease progression.

Who can join the trial?

14 criteria

  • Must be an adult aged 18 years or older.
  • Must have been diagnosed with chronic hepatitis D infection for at least 6 months before joining the study. This should be confirmed by medical records.
  • Must be able to understand and sign a written consent form before starting any study procedures.
  • Must be willing and able to follow the visit schedule and meet the study requirements.
  • For Cohort 1 only: Must have participated in a previous study called MYR-Reg-02 and have the following documented results:
    • Assessment of ascites (fluid in the abdomen) and hepatic encephalopathy (brain disorder due to liver disease) within 3 months before starting BLV treatment.
    • Laboratory tests needed to calculate Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores within 3 months before starting BLV treatment. These tests include:
      • Serum bilirubin (a substance made by the liver).
      • Serum creatinine (a waste product filtered by the kidneys).
      • International normalized ratio (INR) (a measure of blood clotting).
      • Serum albumin (a protein made by the liver).
      • Documentation of fibrosis status (liver scarring) assessment within 6 months before starting BLV treatment by at least one of the following methods:
        • Biopsy (a small sample of liver tissue).
        • FibroScan® (a special scan to check liver stiffness).
        • Measurement of quantitative HDV RNA (amount of virus in the blood) within 3 months before starting BLV treatment.
        • Measurement of alanine aminotransferase (ALT) (an enzyme that indicates liver health) within 3 months before starting BLV treatment.
        • For Cohort 2 only: Participants who are scheduled to receive BLV according to the approved guidelines or have decided to start treatment with BLV and plan to begin treatment.

Who cannot join the trial?

10 criteria

  • Patients with any other type of **hepatitis** infection besides **Chronic Hepatitis D** cannot participate. **Hepatitis** is a disease that affects the liver.
  • Patients who have had a **liver transplant** are not eligible. A **liver transplant** is a surgery to replace a diseased liver with a healthy one from another person.
  • Patients with **severe liver disease** complications, such as **liver cancer**, cannot join. **Liver cancer** is a type of cancer that starts in the liver.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.
  • Patients who have a history of **alcohol or drug abuse** in the past year cannot participate. **Alcohol or drug abuse** means using these substances in a way that is harmful to health.
  • Patients with **severe heart problems** are excluded. **Severe heart problems** refer to serious conditions affecting the heart's function.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with **uncontrolled diabetes** are not eligible. **Uncontrolled diabetes** means that blood sugar levels are not well managed.
  • Patients with **autoimmune diseases** are excluded. **Autoimmune diseases** are conditions where the immune system attacks the body's own cells.
  • Patients who have had a **severe allergic reaction** to similar medications in the past cannot participate. A **severe allergic reaction** is a serious response by the body to a substance.
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Investigated drugs

Bulevirtide is a medication used in the treatment of chronic hepatitis D infection. 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. This can slow down the progression of liver disease and decrease the risk of liver-related complications. In this clinical trial, the focus is on understanding how long-term treatment with bulevirtide affects the health of the liver and the occurrence of liver-related events in patients with chronic hepatitis D.

What is already known about the treatment

Bulevirtide – Bulevirtide is administered as an injection, typically under the skin, to treat chronic Hepatitis D infection. It is currently being studied in clinical trials to understand its long-term effects on liver disease progression. The medication works by blocking the entry of the hepatitis D virus into liver cells, helping to reduce the viral load in the body. Bulevirtide is classified as an antiviral agent, specifically targeting the hepatitis D virus.

Investigated diseases

Chronic Hepatitis D Infection – Chronic Hepatitis D Infection is a liver disease caused by the Hepatitis D virus, which requires the presence of Hepatitis B virus to replicate. The disease progresses as the virus infects liver cells, leading to inflammation and damage over time. This can result in symptoms such as fatigue, abdominal pain, and jaundice. As the infection persists, it may lead to more severe liver damage, including fibrosis and cirrhosis. In advanced stages, complications such as hepatic decompensation, characterized by ascites and hepatic encephalopathy, may occur. The disease can also increase the risk of developing hepatocellular carcinoma, a type of liver cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501901-10-00Protocol codeGS-US-589-6206Estimated enrolment220 patientsSponsorGilead Sciences Inc.

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