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

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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 given as a solution for injection. Participants in the study will either receive Bepirovirsen or a placebo, which looks like the medication but does not contain the active ingredient.

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. The goal is to see if Bepirovirsen can help reduce the virus to very low levels or eliminate it altogether, allowing participants to stop their current hepatitis B treatment.

Throughout the study, participants will be closely monitored to ensure their safety and to assess how well the treatment is working. The study aims to provide valuable information on whether Bepirovirsen can be an effective treatment option for people with chronic hepatitis B, potentially leading to a new way to manage this condition.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including blood tests to check your hepatitis B virus (HBV) levels and liver function.

2 treatment initiation

If eligible, you will begin treatment with either bepirovirsen or a placebo. The medication is administered as a solution for injection under the skin.

The treatment will last for 24 weeks, with specific loading doses designed to help achieve a functional cure of chronic hepatitis B.

3 regular monitoring

Throughout the treatment period, you will have regular visits to monitor your health and the effects of the medication. This includes blood tests to measure HBV levels and liver function.

You will be asked to report any side effects or changes in your health during these visits.

4 treatment completion

After completing the 24-week treatment, you will stop taking the medication. Your health will continue to be monitored to assess the long-term effects of the treatment.

The goal is to achieve a functional cure, meaning the virus is no longer active in your body without the need for ongoing medication.

5 follow-up period

You will have follow-up visits for 24 weeks after stopping the treatment. These visits will help determine if the treatment was successful in achieving a functional cure.

During this period, you will not receive any rescue medication unless necessary.

Who Can Join the Study?

  • Participants must have had a documented chronic Hepatitis B (HBV) infection for at least 6 months before the screening.
  • Participants must be currently receiving stable nucleos(t)ide analogue (NA) 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 Hepatitis B surface antigen (HBsAg) in the blood must be more than 100 IU/mL but less than or equal to 3000 IU/mL. HBsAg is a protein on the surface of the Hepatitis B virus.
  • The concentration of Hepatitis B virus DNA in the blood must be adequately suppressed, meaning it should be less than 90 IU/mL. HBV DNA is the genetic material of the Hepatitis B virus.
  • The level of alanine aminotransferase (ALT) in the blood must be less than or equal to 2 times the upper limit of normal (ULN). ALT is an enzyme that helps break down proteins and is a marker of liver health.
  • 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?

  • Patients with Hepatitis B who are not on NA treatment (a type of medication for Hepatitis B) cannot participate.
  • Patients with a baseline HBsAg level higher than 3000 IU/mL are excluded. HBsAg is a protein on the surface of the Hepatitis B virus.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population are not eligible for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hospital Universitario De Navarra Pamplona Spain
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH Berlin Germany
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Evangelismos S.A. Athens Greece
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD Veliko Tirnovo Bulgaria
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Praxis Ebertplatz Cologne Germany
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Leon Leon Spain
Hospital General Universitario De Valencia Valencia Spain
Katholisches Klinikum Bochum gGmbH Bochum Germany
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
General University Hospital Of Patras Patras Greece
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
University General Hospital Of Alexandroupoli Alexandroupoli Greece
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Centre Hospitalier Universitaire De Rennes Rennes France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Hospital Universitario Virgen De La Victoria Malaga Spain
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Iasi Romania
Hhzlwcnz Uckpzputshgzm Mmfxlyr Db Vanauzlino Santander Spain
Iqctmwhrvolnzkvme Zjhzfqq Skelzscq (igxy Berlin Germany
Nxfxlhpqol Bemmsx Goi Berlin Germany
Pjxbqn Cfby Omq Bzdfwe Berlin Germany
Efunmfjx Fopwe Gxioyhizaet éc Ssxftztvbczh Miskolc Hungary
Cxaifph Mchdtksy w Łgfkxlgo Lancut Poland
Aei Di Lrmobz Latina Italy
Lebbq Gobephv Heflrvni Ow Arawqm Athens Greece
Ctypxh Hxrnsaprpwz Ummlpnazifppq Dg Dknqv Dijon France
Ujaobdajzrxdzfokzxtvq Dkewdgltywo Aqy Duesseldorf Germany
Aixdqmh Odivnvqbyzr Ugzumnprjteub Oodtvwbu Rdxxlxu Foggia Italy
Khxxzsyn dxk Usytavkwniyz Mirjauiq Aag Munich Germany
Mgjkindn Mrtbvag Ayeabnv Pleven Bulgaria
Hsqpagaf Vvpx ddfqmtuj Barcelona Spain
Kxsttcdwy Spltnwh Snwvlnefwxjgxvh iy Jdbu Pkgom Ia Cracow Poland
Hkhvffuz Ustquztdsyywnc Shnmowvbxm &dnjzmu Hfvjwik dj Hdpuvfduzzl STRASBOURG, Alsace France

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
13.01.2023
France France
Not recruiting
13.01.2023
Germany Germany
Not recruiting
13.01.2023
Greece Greece
Not recruiting
13.01.2023
Hungary Hungary
Not recruiting
13.01.2023
Italy Italy
Not recruiting
13.01.2023
Poland Poland
Not recruiting
13.01.2023
Romania Romania
Not recruiting
13.01.2023
Spain Spain
Not recruiting
13.01.2023

Trial locations

Investigated drugs:

Bepirovirsen is a medication being studied for its potential to help people with chronic Hepatitis B. It is designed to work by targeting the virus that causes the infection, with the goal of reducing the virus to very low levels or even eliminating it from the body. This medication is being tested to see if it can help achieve what is known as a “functional cure,” meaning that the virus is controlled so well that it no longer causes harm, even if it is not completely gone. The study is looking at how effective and safe this treatment is for people who are already receiving other treatments for Hepatitis B.

Hepatitis B, Chronic – Chronic Hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It begins with an initial acute phase, which may or may not present symptoms. If the virus is not cleared from the body, it progresses to a chronic phase, where the virus remains in the liver. Over time, this can lead to inflammation and damage to liver cells. The disease can progress slowly, often over decades, and may lead to liver scarring. In some cases, it can result in more severe liver damage.

Trial ID:
2023-504239-41-00
Protocol code:
202009
NCT ID:
NCT05630807
Trial Phase:
Therapeutic confirmatory (Phase III)

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