Study on Bulevirtide Treatment for Patients with Chronic Hepatitis D

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Lille Lille France
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier Universitaire Rouen Rouen France
Hôpital Avicenne Bobigny France
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Gastromedica S.R.L. Iasi Romania
Centre Hospitalier Universitaire De Toulouse Toulouse France
Hospital Clinic De Barcelona Barcelona Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Deutsches Herzzentrum Berlin Berlin Germany
CHU Saint Pierre Brussels Belgium
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Asklepios Klinik St George Hamburg Germany
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Hospital Universitario Torrecardenas Almeria Spain
St. Josefs-Hospital Wiesbaden GmbH Wiesbaden Germany
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu Balotesti Romania
Tirol Kliniken GmbH Hall in Tirol Austria
Hopital Saint Eloi Montpellier France
Hôpital Pontchaillou-CHU Rennes Rennes France
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Iasi Romania
Leber Und Studienzentrum Checkpoint GbR Berlin Germany
Fundeni Clinical Institute Bucharest Romania
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara Timisoara Romania
Uvkmesedac Hobtmyfbf Pdtco Svijilwccdr Cmtaezu Fgbv Paris France
Lxnvopoanfp Clabtl Kiel Germany
Ckv dmwrzjtwyrvukj Epagny Metz Tessy France
Cddgpb Hoahcjnntbc El Uocbxcwauppwn Dw Likhhsj Limoges France
Umdcjckzcofecusqehtla Drlvwopozif Akf Duesseldorf Germany
Mjcorgn Unvawijwim Of Giso Graz Austria
Egdnlmp Udosjvwsozlz Myojunp Cmhrncl Rrnbdoxdg (kvhxpgf Mjn Rotterdam The Netherlands
Gekzvz Ugpjyrewqs Fadpvgtsq Frankfurt Germany
Ujpafjymte Ox Arwqvoc Edegem Belgium
Uytdffowheksodzfuvrsy Epgkr Apz Essen Germany
Crsinz Hgenyloqklr Rrvqpnje Dzvldigvqycrnv Angers France
Ftnhiacqv Pked Lg Iulicymfgsivl Bpptwnvha Dcp Hwdbfhtl Uadeqickblgkc Lv Pta Madrid Spain
Hrwfsgas Vstl dgxhkwaw Barcelona Spain
Hlehcnc Hzash Mwbuxw &kxwpcr 1 rwy Gxynhee Ebdvur Creteil France
Cnj Cmaim Rapkdznhehq Lyon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
16.12.2022
Belgium Belgium
Not recruiting
16.12.2022
France France
Not recruiting
16.12.2022
Germany Germany
Not recruiting
16.12.2022
Romania Romania
Not recruiting
16.12.2022
Spain Spain
Not recruiting
16.12.2022
The Netherlands The Netherlands
Not recruiting
16.12.2022

Trial locations

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.

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 ID:
2022-501901-10-00
Protocol code:
GS-US-589-6206
Trial Phase:
Therapeutic confirmatory (Phase III)

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