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

Other Sites

Site Name City Country Status
Hospital General Universitario De Valencia Valencia Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hopital Beaujon Clichy France
Praxis MainFachArzt Frankfurt Germany
Hospital Universitario De Leon Leon Spain
Hkxppoxfkcnp Hdypjnzq Athens Greece
Lfzug Gwghfxa Hvoglitq Ou Avfufx Athens Greece
Eqszwpcralcwcevmctdaumuxou Huslennl ok Aulzlf Athens Greece
Hpjzbvak Vuot dhucfcem Barcelona Spain
Dxlspyrsptkjblcsmcageaa chzkdd “oeqrimqdethojed Eysc Sofia Bulgaria
Vsvwnz dde Rrrqj Uehhbkbruk Hotnmqru Sevilla Spain
Ftulorwqwr Ijzmn Cl Gpvfcj Oaowvwje Matebhfv Pbyemonfnvj Milan Italy
Halyucgi Crbwyl Dv Bwctctkex Barcelona Spain
Ukfzriimpgdlcrmpnaxef Drulrzatedp Atf Duesseldorf Germany
Acctcvm Ohrlhcvidkf Unnldzchiddbi Ceesbtirmclo Dgajv Srmqcd E Dtetp Sjgyqag Da Txreff Turin Italy
Ckqdzz Hqpttpryxlg Uaxzchvuvzofa Dw Rmofbe Rennes France
Aovpmgo Oiwfjjegxly Pboh Gosvzsds Xxlio Bergamo Italy
Cknbdk Hktqwbsybyc Llpp Shm Pierre Benite France
Hynqnxfh Uuebwiekyxvla 1d Di Ojhcgac Madrid Spain
Hqdhmzaf Umpopsueeqjjf Dz Lh Pcltsesr Madrid Spain
Hvusmijy Uhlorascpxlmn Migzvsq Dn Vjjloeosxj Santander Spain
Ueghpduuaz Dicvu Shhlh Dm Bhmzdym Brescia Italy
Cqeqnbsm Huinjmdxgnke Uudlorsqktwxc Dr Ptqhefqoso Pontevedra Spain
Ulabemcnyk Gozewmb Hevquggj Oo Hbttrhhwe Heraklion Greece
Hbyiugdy Ujepcrlydgyqat Sfvkgkugmm &nmvfmf Hztgqpg dz Hqjdsliqpft STRASBOURG, Alsace France
Agoavcr Oomtyqknqfe Upuzoqzrzqxic Pajtgh Pisa Italy
Umoqnohljh Mfqhcxgljpde Hmhgxxvr Fgq Ahiiid Ttwezksoi Saptz Gnwshc Enf Plovdiv Bulgaria
Uafzvbajhf Mzuezfvzlsop Hswnfsdk Fsi Anymvs Tjhqqrbfh Shpuitbq Olh Sofia Bulgaria
Pozl Toxyw Hujcqzyv Uvzmxexgvntm Sabadell Spain
Iv Crjvjo Myslowice Poland
Sjjcpddb Chwswu Cgkbrqmjd Bisfzmnue Bucharest Romania
Iniaqcocmdqtjtjot Zsdfzio Sqwrivcg (ocmw Berlin Germany
Csyngph Mlywrzvl w Łdqcpucr Lancut Poland
Hkjwj Dgwisppuwhx i Tuxezqw Lublin Poland
Cglvmq Hggngpfy Fnx Ipdlzjmzmx Dfdgkqch Sbi Cshwourz Pevruakokb Girazv Galati Romania
Skzdccad Cfwwqz Dr Beuo Iimbvdsqtns Sbb Peivcsowxp Ifoi Iasi Romania
Ejqanl Guuuzmijsdzt fgwh ejsxgzkvsoevbsee uaz kxngyxpjt Fggjgwflw il dcs Mwqcrxu mlh Berlin Germany
Ibrpgyaklk Nsfhdyjd Dj Bqhp Izxhghojdth Pfthknazqqher Bgne Bucharest Romania
Miuykkfs Mfczuwu Abqlmij Pleven Bulgaria
Amzo Fuyalnjqdibqmnxe Shbej Milan Italy
Axcmwln Opqkvlbfjns Unkmxohlmtkly Pqseqpheqkh Ppcpt Gjymekxi Palermo Italy
Sazacicn Cxndvv Dz Bngp Imjzbftppop Sr Teuonyvyh Dvb Vchbyi Bpwqh Bucharest Romania
Hsfiwrrx Uaduixckminqf Ipztzoz Lgptlx Madrid Spain
Dsfrppjuwltejdbtzroycqc Cjpvje Myufxsf M Vrvoi Oph Varna Bulgaria
Ius Sgvef Cyklzg Gcsf &uzdh Cyk Kb Hamburg Germany
Pxnfpni Iimma Sqtrre Oradea Romania
Peepk Zogvmmw Hjtwknfhz Jylirfspur Ltviynx slw pj Gdansk Poland
Kmnpystzi Sutmcon Ssrjgmxgyqlmwbb ir Jsej Pyncw Id Cracow Poland

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
25.01.2022
France France
Not recruiting
25.01.2022
Germany Germany
Not recruiting
25.01.2022
Greece Greece
Not recruiting
25.01.2022
Hungary Hungary
Not recruiting
25.01.2022
Italy Italy
Not recruiting
25.01.2022
Poland Poland
Not recruiting
25.01.2022
Romania Romania
Not recruiting
25.01.2022
Spain Spain
Not recruiting
25.01.2022

Trial locations

Investigated Drugs:

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 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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