Study on Bepirovirsen for Patients with Chronic Hepatitis B Receiving Nucleos(t)ide Analogue Treatment

1 1

What is this study about?

This clinical trial is focused on studying the treatment of Chronic Hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The study will use a medication called Bepirovirsen, which is administered as a solution for injection. Participants in the study will either receive Bepirovirsen or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness and safety of Bepirovirsen in achieving a functional cure for individuals with chronic hepatitis B who are already being treated with nucleos(t)ide analogues, a type of medication that helps control the virus. The study will last for 24 weeks, during which participants will receive Bepirovirsen with initial higher doses to help achieve the desired treatment effect.

Throughout the study, participants will be monitored to assess the impact of the treatment on their condition. The goal is to determine if Bepirovirsen can help achieve a functional cure, meaning the virus is controlled without the need for ongoing medication. This study is part of a larger effort to find effective treatments for chronic hepatitis B and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the participant is confirmed to have chronic hepatitis B virus (HBV) infection for at least 6 months and is currently on a stable nucleos(t)ide analogue (NA) therapy.

The participant’s HBV DNA levels are checked to ensure they are adequately suppressed, and their alanine aminotransferase (ALT) levels are within the acceptable range.

2 treatment initiation

The participant begins treatment with bepirovirsen, administered as a solution for injection under the skin (subcutaneous use).

The dosage is 150 mg/mL, and the treatment includes loading doses to achieve a functional cure.

3 treatment duration

The treatment with bepirovirsen continues for a period of 24 weeks.

During this time, the participant remains on their stable NA therapy without any changes.

4 treatment assessment

The main objective is to assess the treatment effect of bepirovirsen in achieving a functional cure for chronic HBV infection.

The primary endpoint is to determine if a functional cure is maintained for 24 weeks after stopping all chronic HBV treatments, including bepirovirsen, placebo, and NA, without the need for rescue medication.

5 end of study

The study is estimated to conclude by June 24, 2026.

Participants are monitored for the primary endpoint and any potential side effects throughout the study duration.

Who Can Join the Study?

  • Participants must have a documented chronic Hepatitis B (HBV) infection for at least 6 months before the screening.
  • Participants should be currently receiving stable NA (nucleos(t)ide analogue) therapy, which means no changes to their NA treatment for at least 6 months before the screening and no planned changes during the study.
  • The concentration of HBsAg (Hepatitis B surface antigen) in the blood should be more than 100 IU/mL but not more than 3000 IU/mL.
  • The concentration of HBV DNA in the blood must be adequately suppressed, meaning it should be less than 90 IU/mL.
  • The level of alanine aminotransferase (ALT), an enzyme found in the liver, should be no more than 2 times the upper limit of normal (ULN).
  • Participants must be willing and able to stop their NA treatment according to the study protocol.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Individuals with Hepatitis B who are not on NA treatment. NA treatment refers to medications that help control the virus.
  • Individuals with a baseline HBsAg level greater than 3000 IU/mL. HBsAg is a protein on the surface of the Hepatitis B virus, and its level indicates the amount of virus in the blood.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Centre Hospitalier Universitaire Rouen Rouen France
ASST Fatebenefratelli Sacco Milan Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Hospital Universitario Rio Hortega Valladolid Spain
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Torrecardenas Almeria Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Pelican Impex S.R.L. Oradea Romania
NZOZ Przychodnia Specjalistyczna Gemini Zychlin Poland
ICH Study Center GmbH & Co. KG Hamburg Germany
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Azienda Ospedaliera di Padova Padua Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Hippokration Hospital Athens Greece
ID Clinic Myslowice Poland
Hospital Unviersitario Miguel Servet Zaragoza Spain
Hospital Universitario Clínico San Cecilio Granada Spain
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Di Pisa Pisa Italy
Spitalul Clinic De Boli Infectioase Constanta Constanta Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Praxis MainFachArzt Frankfurt Germany
University Of Szeged Szeged Hungary
Hkfyqdpo Uwpxaoqplbjfi Dj Lq Pnzbbygw Madrid Spain
Hoacxgmh Uiclgfjkutnep Dr Btgqlge Badajoz Spain
Hdgmanew Uwbgpylgghlxz Dw Cjmvgfv Caceres Spain
Syxappxa Ctddqu &srovgzcyb Iz Cofevoxhbelhljxyux Bucharest Romania
Crjozk Htycwjrb Fsl Ixeitghqvm Dpvuueci Ski Cruuhdev Pwerbhhnpi Gevpph Galati Romania
Scdsgzof Cclyut De Bnft Ioizlyjpzer Cpljchqzuoj Cluj Napoca Romania
Pdpxg Zeglcli Hrwefykcb Jroljijick Losdjsz snu pj Gdansk Poland
Pphz Tojpe Hfglopda Uxjsxapmjupd Sabadell Spain
Hjyxxisu Ufzuxupyqtgwy Fvlcsjawq Alqizyex Madrid Spain
Ccaevh Hhveyfwocmf Eg Ugciiafcgfwht Dr Lqexmmq Limoges France
Ahsfjpq Obstjahbqbf Ucehcaniuuwpp Cxbtkgwepwne Dfswk Sbhgkp E Djbui Sdghcig Dj Tydxsi Turin Italy
Gyvfpc Upitzrscex Frwdwyjbm Frankfurt Germany
Fezetpsss Pcxs Lw Ioeshmbzwdpew Bleasojqu Dhf Hgifiojl Upsltrythwocu Lc Pkx Madrid Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
21.12.2022
France France
Not recruiting
21.12.2022
Germany Germany
Not recruiting
21.12.2022
Greece Greece
Not recruiting
21.12.2022
Hungary Hungary
Not recruiting
21.12.2022
Italy Italy
Not recruiting
21.12.2022
Poland Poland
Not recruiting
21.12.2022
Romania Romania
Not recruiting
21.12.2022
Spain Spain
Not recruiting
21.12.2022

Trial locations

Investigated drugs:

Bepirovirsen is a medication being studied for its potential to help people with chronic Hepatitis B virus infection. It is being tested to see if it can provide a functional cure for those who are already receiving treatment with nucleos(t)ide analogues. The study involves using bepirovirsen for a period of 24 weeks, with initial higher doses to see if it can effectively reduce the virus in the body.

Investigated diseases:

Hepatitis B, Chronic – This is a long-term infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to the liver over time. The disease progresses slowly, often without symptoms in the early stages. As it advances, it may cause symptoms such as fatigue, jaundice, and abdominal pain. Chronic hepatitis B can lead to more serious liver conditions, such as cirrhosis or liver cancer. The virus is primarily spread through contact with infectious body fluids.

Trial ID:
2023-504238-23-00
Protocol code:
219288
NCT ID:
NCT05630820
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study comparing ALG-000184 with tenofovir disoproxil in untreated adults with chronic hepatitis B virus infection

    Recruiting

    1 1
    Investigated diseases:
    Bulgaria France Italy Romania Spain
  • A study to evaluate the safety and effectiveness of MRNA3771 and GRNA1599 in adults with chronic hepatitis B

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France