Long-term Study on Treatment Response in Chronic Hepatitis B Patients Using Bepirovirsen

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What is this study about?

This clinical trial is focused on studying the long-term effects of a treatment for Chronic Hepatitis B, a liver infection caused by the hepatitis B virus. The treatment being evaluated is called bepirovirsen, which is administered as a solution for injection. This study is designed to observe how well the treatment response lasts over time in participants who have previously been treated with bepirovirsen, with or without additional nucleos(t)ide therapy, which is another type of medication used to manage hepatitis B.

The purpose of the study is to understand the durability of the treatment response. Participants in this study will have their health monitored over a period of time to see how their condition progresses after receiving bepirovirsen. The study will involve regular check-ups to assess the levels of certain markers in the blood that indicate the presence of the hepatitis B virus and the body’s response to the treatment. These markers include HBsAg, which is a protein on the surface of the hepatitis B virus, and HBV DNA, which is the genetic material of the virus.

Throughout the study, researchers will also look for any signs of the virus returning or any need for additional medication. The study aims to provide valuable information on how effective bepirovirsen is in maintaining a long-term response in people with chronic hepatitis B, helping to improve future treatment strategies for this condition.

1 joining the study

Upon joining the study, participants are required to have previously participated in a bepirovirsen treatment study for chronic hepatitis B.

Participants must have achieved specific treatment responses in their previous study to be eligible for this follow-up study.

2 treatment administration

The study involves the administration of bepirovirsen, which is a solution for injection given subcutaneously.

Participants who are on stable nucleos(t)ide analog (NA) therapy may need to cease their NA treatment according to a specific schedule.

3 monitoring and follow-up

Participants will be monitored for the long-term durability of their treatment response.

Regular assessments will be conducted to measure levels of hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) DNA, and other relevant markers.

4 end of study

The study is estimated to conclude by March 24, 2029.

Participants will have their final assessments to evaluate the outcomes of the treatment and any long-term effects.

Who Can Join the Study?

Participants must have Chronic Hepatitis B, which is a long-lasting infection of the liver caused by the hepatitis B virus.
Participants who are currently on stable NA (nucleos(t)ide analogues, a type of medication) must be willing and able to stop their NA treatment according to the study’s schedule.
Participants must be capable of giving informed consent, meaning they understand the study and agree to participate.
Participants from specific previous studies (B-Clear, B-Together, B-Fine) must have received at least one dose of bepirovirsen (a study medication) and either:
- Achieved a PSPO (primary study protocol objective) and maintained a response until the end of their previous study, or
- Shown a reduction in HBsAg (hepatitis B surface antigen, a protein on the surface of the virus) and HBV DNA (the virus’s genetic material) for 24 weeks after stopping treatment, without needing additional medication, and maintained this until the end of their previous study.
Participants from other specific studies (B-Well 1 & 2) must have received at least one dose of bepirovirsen (or a placebo) and either:
- Stopped NA treatment at Week 48 in their previous study and achieved certain levels of HBsAg and HBV DNA by the end of the study (Week 96), or
- Met criteria to stop NA treatment at Week 48 but continued treatment, maintaining certain levels of HBsAg and HBV DNA by the end of the study (Week 72), or
- Did not meet criteria to stop NA treatment in their previous study but achieved certain levels of HBsAg and HBV DNA by the end of the study (Week 72).
Participants from another specific study (TH HBV ASO-001) must have received at least one dose of bepirovirsen and either:
- Achieved certain levels of HBsAg and HBV DNA at specific weeks in their previous study and maintained these levels by the end of the study, or
- Did not achieve these levels at specific weeks but did so by the end of the study.
Participants can be of any gender.
The study includes vulnerable populations, meaning groups that may need special protection or consideration.

Who Cannot Join the Study?

Patients with other serious liver diseases besides Chronic Hepatitis B cannot participate. This means if you have another liver condition, you may not be eligible.
Patients who have had a liver transplant are not eligible. A liver transplant is when a damaged liver is replaced with a healthy one from a donor.
Patients who are pregnant or breastfeeding cannot take part in the study. This is to ensure the safety of both the mother and the baby.
Patients with a history of alcohol or drug abuse may be excluded. This refers to using alcohol or drugs in a way that is harmful to your health.
Patients who are unable to follow the study procedures or attend study visits may not be eligible. This means if you cannot commit to the study schedule, you might not be able to participate.
Patients with certain medical conditions that could interfere with the study results may be excluded. This means if you have a health issue that could affect the study, you might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD	Sliven	Bulgaria

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Hospital Universitario Infanta Leonor	Madrid	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
University General Hospital Of Heraklion	Heraklion	Greece
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Pelican Impex S.R.L.	Oradea	Romania
Praxis MainFachArzt	Frankfurt	Germany
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes	Bucharest	Romania
ICH Study Center GmbH & Co. KG	Hamburg	Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Hippokration Hospital	Athens	Greece
ID Clinic	Myslowice	Poland
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Leon	Leon	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin	Germany
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi	Iasi	Romania
Hubjdftg Unfpzqxesdxou Dt Li Pdhjdrsv	Madrid	Spain
Hlwbrbiu Ujkmjmztfenke Mbgltjr Dt Vumpuctxuy	Santander	Spain
Cigmcun Mtlqbkel w Łljzwnep	Lancut	Poland
Huzlx Dmoudfszflc i Tlalnex	Lublin	Poland
Cmwpxv Hxjpkuhu Fko Iemvlggfek Dnnnbqwj Sib Cuatofca Pbekxyzznn Gprtir	Galati	Romania
Ivyxosnypvizvgnwn Zyomcxu Smsxgysq (ntyo	Berlin	Germany
Pyuou Zsikfjt Hdaxzzsjr Jozzrsizlq Lkqpdru seh px	Gdansk	Poland
Pnsa Tqsgd Htmxnwxp Uwwgeosagfjz	Sabadell	Spain
Lhbdq Gpufluh Hkmvypqd Od Annpta	Athens	Greece
Amysjyy Oprnqyycooe Uugljytlpntqm Czwqbhdjjcil Dgbsj Sjxzlo E Drsyr Shuyzos Dy Tbpigp	Turin	Italy
Mtpueanv Msjlifr Ahbzzbu	Pleven	Bulgaria
Ajalglc Ohootyfyajh Pbqm Ghmmkqer Xgirk	Bergamo	Italy
Ejsrleibcgroswjqwifuhtoswu Hbzimdwd oz Afcqvm	Athens	Greece
Uashqlvouqufwahketrkn Dwjahixzntc Acy	Duesseldorf	Germany
Hummteuh Vwmr dfzbhnbj	Barcelona	Spain
Kuysimyzg Ssakdbr Snnpaqiutvunsmf ii Jpna Pksnv In	Cracow	Poland
Hbzqjwpl Utzchvqqohipfg Slctvnvkcj &lggkta Hkijgnx dg Hqxfdqcvvfe	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	25.01.2022
France	Not recruiting	25.01.2022
Germany	Not recruiting	25.01.2022
Greece	Not recruiting	25.01.2022
Hungary	Not recruiting	25.01.2022
Italy	Not recruiting	25.01.2022
Poland	Not recruiting	25.01.2022
Romania	Not recruiting	25.01.2022
Spain	Not recruiting	25.01.2022

Trial locations

Investigated drugs:

Bepirovirsen

Bepirovirsen is a medication being studied for its effects on chronic hepatitis B. It is designed to help reduce the amount of hepatitis B virus in the body. The trial aims to evaluate how well the treatment response lasts over time in participants who have previously received bepirovirsen.

Nucleos(t)ide Therapy refers to a group of antiviral medications commonly used to treat chronic hepatitis B. These medications work by interfering with the virus’s ability to replicate, helping to control the infection and reduce liver damage. The study includes participants who have been treated with these therapies to assess the long-term effects of their treatment.

Investigated diseases:

Chronic hepatitis B

Chronic Hepatitis B – Chronic Hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to liver cells over time. The disease progresses slowly, often without noticeable symptoms in the early stages. As it advances, individuals may experience fatigue, jaundice, and abdominal discomfort. The virus can remain in the body for years, potentially leading to liver cirrhosis or liver cancer. Regular monitoring is essential to manage the condition and prevent complications.

Trial ID:

2023-506867-33-01

Protocol code:

206882

NCT ID:

NCT04954859

Trial Phase:

Therapeutic exploratory (Phase II)

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Long-term Study on Treatment Response in Chronic Hepatitis B Patients Using Bepirovirsen

What is this study about?

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