Study on Bepirovirsen for Patients with Chronic Hepatitis B Receiving 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 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

Site Name	City	Country
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Oncopole Claudius Regaud	Toulouse	France
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
CHU Grenoble Alpes	La Tronche	France
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD	Sliven	Bulgaria
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Beaujon	Clichy	France
Praxis MainFachArzt	Frankfurt	Germany
Aidstkr Omfzbqibpov dy Pgyfti	Padua	Italy
Hzeihxgadndi Hjkzgerj	Athens	Greece
Vmcrwp dkf Rffmn Unnaaixtow Hvgaylrx	Sevilla	Spain
Adfbcsn Oldjqdrbbjr Ucelrceiewhqs Clfzpcfgtmlt Despi Sgylko E Dmuyj Sjtxzwf Dj Tksedo	Turin	Italy
Ujycmteuac Oh Sneemi	Szeged	Hungary
Clgfhk Hfnshpbrbwp Lgqu Shp	Pierre Benite	France
Hpofcnxt Uoztvqcmaqokp Dl Lk Pcjtyykk	Madrid	Spain
Fqwykzzbi Poeu Lj Iaeqjjvwejdjo Bphsyxvml Dfh Hiuesomn Uzcsfrspudycw Lz Pyq	Madrid	Spain
Hyhkopnt Uttbctlvaccpq Rkq Hlntumg	Valladolid	Spain
Hyiqhvvl Cciajet Uvvnpdmouzchb Lsgyii Bymrt	Zaragoza	Spain
Uznejzfswb Ggcvifs Hshxifwh Oq Hnjsgcpaj	Heraklion	Greece
Idwqlkppva Gpguvux Hjadlukq Ov Twyujjbainmz	Thessaloniki	Greece
Ipj Peqcnjogpma Gyuc &pxck Cyu Ky	Frankfurt	Germany
Fwpif Vmdiqsnie Svlne Gohkwju Eyyyfvyc Opmmwi Kflile	Szekesfehervar	Hungary
Ugtrfqdpbw Myoocmbnjpmj Hgeolxjn Fbb Aalozj Tnyzjgyuy Soyrf Gccpht Ebk	Plovdiv	Bulgaria
Ujsfrkkkpg Mfqjaexnbbua Hrdadjzb Frc Amvejq Tbowzzqxj Sutdqkqy Ojj	Sofia	Bulgaria
Pqdp Tdlbp Hskrxdcf Ukhykingqxnb	Sabadell	Spain
Io Cckmqi	Myslowice	Poland
Nrwn Phmmmglexiz Svvkjgbvkgfreah Gsqhvo	Zychlin	Poland
Ckdurs Hmdqxiel Fnj Iqbqsuesqk Doplrzvg Sii Cwgvzqff Puavszbntv Gbsaji	Galati	Romania
Svsqsncj Cyayqu &ecsozjbgf Ie Cwcftywlczhkdpbmtu	Bucharest	Romania
Sldinrnm Crbhuc Dv Bkjw Ihbwjjayidd Cupgpsaoqzd	Cluj Napoca	Romania
Cocqjo Hqtbigntqji Eq Ubgfcmayutuoh Dz Liceaca	Limoges	France
Utvkppdodszlgfaza Di Pvbz	Pisa	Italy
Gkjtcp Udhfrtdvez Fcknoowph	Frankfurt	Germany
Soqtjisi Cvhfjo De Bunc Ibcppekcqmu Cgzmbfgbq	Constanta	Romania
Ahah Fnnzmezqzdlshane Szbdh	Milan	Italy
Aqzqssi Ofievtqrniw Urpkwqhjeqhwq Prgmdmsksmv Pqhul Gtbikqit	Palermo	Italy
Hvinwzpa Uufvjetqjcduv Da Bqfvhvw	Badajoz	Spain
Spectkwr Cmotcu Dk Bzmz Ikkmiqzmukj Sa Thzvopkii Dqi Vreobl Banfi	Bucharest	Romania
Hhnbxoxc Urhjhlpvvjcyu Iepmhai Lxbwkx	Madrid	Spain
Hpnbpakn Uuqozdlinwjqs Tnxokulxstkzd	Almeria	Spain
Duhkxzyxrqbnnxmzkfjaifv Czbehf Mubwbyh M Vlduc Oyq	Varna	Bulgaria
Isj Sckew Cqgutv Gavr &eabz Cqt Kq	Hamburg	Germany
Pywaeao Ikalf Sweteu	Oradea	Romania
Pdfuu Zdvtbpx Hfxukxqxl Jmaarlvqzt Lfqxndv shs pr	Gdansk	Poland

Trial status

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

Trial locations

Investigated Drugs:

Bepirovirsen

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:

Chronic hepatitis B

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)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?