Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Hepatitis b breakthrough? study checks if bepirovirsen response lasts

NCT ID NCT04954859

Knowledge-focused Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows about 360 people with chronic hepatitis B who had a good response to the experimental drug bepirovirsen in earlier trials. No new drug is given; researchers simply monitor whether the response lasts over time. Participants may or may not continue standard antiviral therapy. The goal is to see if a short treatment can lead to long-term disease control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that a short course of bepirovirsen leads to long-lasting control of hepatitis B without needing ongoing medication.
What could go wrong
This is an observational follow-up, not a new treatment test. It only includes people who already responded, so results may not apply to all hepatitis B patients. The number of participants is small, and long-term durability is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule. * Capable of giving informed consent. For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine): * Participants who have previously received at least one dose of bepirovirsen AND 1. Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR 2. Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (\<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study. For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2): * Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND 1. NA cessated at Week 48 in parent study and achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at the EOS visit (Week 96) in the parent study OR 2. Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study OR 3. Did not achieve NA cessation criteria in parent study but achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study. For participants rolling over from 217023 (TH HBV ASO-001): * Participants who have previously received at least 1 dose of bepirovirsen AND 1. Achieved HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg \< 1 IU/ml and HBV DNA \<LLOQ, at the EOS study visit \[Week 133 ASO12 arm), or Week 145 (ASO24 arm)\] in parent study OR 2. Did not achieve HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg \< 1 IU/ml and HBV DNA \< LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) in the parent study. Exclusion Criteria: * Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen. * Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hepatitis B are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B

Contacts and locations

Locations

  • GSK Investigational Site

    Sacramento, California, 95817, United States

  • GSK Investigational Site

    San Jose, California, 95128, United States

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02114, United States

  • GSK Investigational Site

    Detroit, Michigan, 48202, United States

  • GSK Investigational Site

    La Plata, Buenos Aires, B1902AWL, Argentina

  • GSK Investigational Site

    Buenos Aires, C1181ACH, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    Rosario, 2000, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Herston, Queensland, 4029, Australia

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Aracaju, Sergipe, 49055-000, Brazil

  • GSK Investigational Site

    Campinas, 13060-803, Brazil

  • GSK Investigational Site

    Curitiba, 30140-073, Brazil

  • GSK Investigational Site

    Manaus, 69040000, Brazil

  • GSK Investigational Site

    São Paulo, 05403-000, Brazil

  • GSK Investigational Site

    Vila Mariana, 04121-000, Brazil

  • GSK Investigational Site

    Plovdiv, 4000, Bulgaria

  • GSK Investigational Site

    Sliven, 8800, Bulgaria

  • GSK Investigational Site

    Sofia, 1431, Bulgaria

  • GSK Investigational Site

    Sofia, 1463, Bulgaria

  • GSK Investigational Site

    Sofia, 1606, Bulgaria

  • GSK Investigational Site

    Varna, 9010, Bulgaria

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6, Canada

  • GSK Investigational Site

    Victoria, British Columbia, V8R 6R3, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 0A9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2, Canada

  • GSK Investigational Site

    Beijing, 100015, China

  • GSK Investigational Site

    Beijing, 100039, China

  • GSK Investigational Site

    Beijing, 100050, China

  • GSK Investigational Site

    Chengdu, 610041, China

  • GSK Investigational Site

    Chengdu, 610072, China

  • GSK Investigational Site

    Chongqing, 400042, China

  • GSK Investigational Site

    Fuzhou, 350028, China

  • GSK Investigational Site

    Guangzhou, 510000, China

  • GSK Investigational Site

    Guangzhou, 510440, China

  • GSK Investigational Site

    Guangzhou, 510630, China

  • GSK Investigational Site

    Hangzhou, 310014, China

  • GSK Investigational Site

    Hangzhou, 310022, China

  • GSK Investigational Site

    Kunming, 650021, China

  • GSK Investigational Site

    Liuzhou, China

  • GSK Investigational Site

    Shanghai, 200025, China

  • GSK Investigational Site

    Shanghai, 200040, China

  • GSK Investigational Site

    Shanghai, 201508, China

  • GSK Investigational Site

    Shenzhen, 518112, China

  • GSK Investigational Site

    Tianjin, 300000, China

  • GSK Investigational Site

    Ürümqi, 830054, China

  • GSK Investigational Site

    Wuhan, 430030, China

  • GSK Investigational Site

    Xi'an, 710061, China

  • GSK Investigational Site

    Xiamen, 361015, China

  • GSK Investigational Site

    Zhenjiang, China

  • GSK Investigational Site

    Zunyi, 563114, China

  • GSK Investigational Site

    Clichy, 92110, France

  • GSK Investigational Site

    Lyon, 69317, France

  • GSK Investigational Site

    Paris, France

  • GSK Investigational Site

    Pessac, 33604, France

  • GSK Investigational Site

    Rennes, 35000, France

  • GSK Investigational Site

    Strasbourg, 67200, France

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • GSK Investigational Site

    Berlin, 12157, Germany

  • GSK Investigational Site

    Berlin, 12163, Germany

  • GSK Investigational Site

    Frankfurt am Main, 60329, Germany

  • GSK Investigational Site

    Hamburg, 20146, Germany

  • GSK Investigational Site

    Athens, 10676, Greece

  • GSK Investigational Site

    Athens, 11527, Greece

  • GSK Investigational Site

    Heraklion, 711 10, Greece

  • GSK Investigational Site

    Kowloon, Hong Kong

  • GSK Investigational Site

    Pokfulam, Hong Kong

  • GSK Investigational Site

    Budapest, 1097, Hungary

  • GSK Investigational Site

    Belagavi, 590010, India

  • GSK Investigational Site

    Coimbatore, 641005, India

  • GSK Investigational Site

    Hyderabad, India

  • GSK Investigational Site

    Kanchan Bagh Hyderabad, 40000, India

  • GSK Investigational Site

    Mumbai, 400008, India

  • GSK Investigational Site

    Mumbai, 400012, India

  • GSK Investigational Site

    Mumbai, 400022, India

  • GSK Investigational Site

    New Delhi, 110070, India

  • GSK Investigational Site

    Pune, 411001, India

  • GSK Investigational Site

    Surat, 395002, India

  • GSK Investigational Site

    Bergamo, 24127, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Modena, 40126, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Pisa, 56124, Italy

  • GSK Investigational Site

    Gifu, 500-8717, Japan

  • GSK Investigational Site

    Gifu, 503-8502, Japan

  • GSK Investigational Site

    Hiroshima, 730-8619, Japan

  • GSK Investigational Site

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    Hokkaido, 006-0811, Japan

  • GSK Investigational Site

    Ishikawa, 920-8650, Japan

  • GSK Investigational Site

    Kagawa, 760-8557, Japan

  • GSK Investigational Site

    Kumamoto, 860-8556, Japan

  • GSK Investigational Site

    Kumamoto, 862-8655, Japan

  • GSK Investigational Site

    Miyagi, 980-8574, Japan

  • GSK Investigational Site

    Niigata, 950-1104, Japan

  • GSK Investigational Site

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    Tokyo, 113-8519, Japan

  • GSK Investigational Site

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

    Tokyo, 180-8610, Japan

  • GSK Investigational Site

    Yamaguchi, 750-0061, Japan

  • GSK Investigational Site

    Kuala Terengganu, 20400, Malaysia

  • GSK Investigational Site

    Auckland, 01042, New Zealand

  • GSK Investigational Site

    Panama City, 7196, Panama

  • GSK Investigational Site

    Cebu City, 6000, Philippines

  • GSK Investigational Site

    Silang, 4118, Philippines

  • GSK Investigational Site

    Gdansk, 80-405, Poland

  • GSK Investigational Site

    Krakow, 31-202, Poland

  • GSK Investigational Site

    Lublin, Poland

  • GSK Investigational Site

    Mysłowice, 41-400, Poland

  • GSK Investigational Site

    Żychlin, 62-571, Poland

  • GSK Investigational Site

    Łańcut, 37-100, Poland

  • GSK Investigational Site

    Bucharest, 020125, Romania

  • GSK Investigational Site

    Bucharest, 021105, Romania

  • GSK Investigational Site

    Bucharest, 030303, Romania

  • GSK Investigational Site

    Craiova Dolj, 417307, Romania

  • GSK Investigational Site

    Galati, 800179, Romania

  • GSK Investigational Site

    Oradea, 410469, Romania

  • GSK Investigational Site

    Chelyabinsk, 454052, Russia

  • GSK Investigational Site

    Moscow, 121170, Russia

  • GSK Investigational Site

    Novosibirsk, 630099, Russia

  • GSK Investigational Site

    Saint Petersburg, 190103, Russia

  • GSK Investigational Site

    Saint Petersburg, 191167, Russia

  • GSK Investigational Site

    Samara, 443063, Russia

  • GSK Investigational Site

    Красноярск, 660049, Russia

  • GSK Investigational Site

    Singapore, 119074, Singapore

  • GSK Investigational Site

    Singapore, 169608, Singapore

  • GSK Investigational Site

    Singapore, 529889, Singapore

  • GSK Investigational Site

    Durban, 4091, South Africa

  • GSK Investigational Site

    Johannesburg, 1830, South Africa

  • GSK Investigational Site

    Ansan-si Gyenggi-do, 15355, South Korea

  • GSK Investigational Site

    Busan, 47392, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seoul, 03312, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 08308, South Korea

  • GSK Investigational Site

    HebrOn, 08035, Spain

  • GSK Investigational Site

    León, 24080, Spain

  • GSK Investigational Site

    Madrid, 28031, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Vigo, 36071, Spain

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 824, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 833, Taiwan

  • GSK Investigational Site

    Taichung, 40447, Taiwan

  • GSK Investigational Site

    Tainan, 70403, Taiwan

  • GSK Investigational Site

    Taipei, 10002, Taiwan

  • GSK Investigational Site

    Taipei County, 104, Taiwan

  • GSK Investigational Site

    Taoyuan, 333, Taiwan

  • GSK Investigational Site

    Bangkok, 10330, Thailand

  • GSK Investigational Site

    Bangkok, 10400, Thailand

  • GSK Investigational Site

    Chiang Mai, 50200, Thailand

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110, Thailand

  • GSK Investigational Site

    Cottingham, HU16 5JQ, United Kingdom

  • GSK Investigational Site

    Liverpool, L7 8XP, United Kingdom

  • GSK Investigational Site

    London, SW9 8RR, United Kingdom

  • GSK Investigational Site

    London, WC1E 6JB, United Kingdom

  • GSK Investigational Site

    Plymouth, PL68DH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.