A Phase 4 interventional study of Bepirovirsen in Hepatitis B, sponsored by GlaxoSmithKline. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
This multi-country, longitudinal follow-up study will enrol adults with chronic hepatitis B (CHB) who previously participated in the Phase III B-Well-1 ((202009: NCT05630807) or B-Well-2 (219288: NCT05630820) studies, received 24 weeks of Bepirovirsen treatment, and achieved hepatitis B surface antigen (HBsAg) levels less than or equal to (\<=) 100 International units per millilitres (IU/mL) at Week 72 without achieving functional cure. No investigational treatment will be administered in this study. Participants will be followed approximately every 6 months for up to 4 years, and retrospective data will be collected from Week 72 of the parent study until enrolment. The study aims to evaluate the long-term durability of HBsAg suppression and disease-related outcomes. The study will end at the last visit of the last participant globally (Month 48). The primary objective of the study is to describe the long-term durability of HBsAg reduction in participants who achieved HBsAg levels ≤100 IU/mL at Week 72 following 24 weeks of Bepirovirsen treatment.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 303 is above the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Compared within Hepatitis B, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hepatitis B. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who received Bepirovirsen in B-Well studies (202009: NCT05630807) or B-Well-2 (219288: NCT05630820) will be enrolled in the study. No study intervention will be administered in this study.
Drug: Bepirovirsen
No study medication will be administered in this study. Eligible participants who received bepirovirsen in the parent studies will be included.
Time From B-Well Week 72 to Confirmed Loss of Response
Confirmed loss of response is defined as HBsAg greater than (\>)100 IU/mL at two consecutive assessments.
Time frame: From B-Well Week 72 assessment up to Month 48
Absolute HBsAg Value at Each Follow-up Assessment
Time frame: From B-Well Week 72 assessment up to Month 48
Change From Week 72 in HBsAg Level at Each Follow-up Assessment
Time frame: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Maintaining or Achieving Predefined HBsAg Thresholds
Thresholds of interest include HBsAg \<= 100 IU/mL, HBsAg \<= 10 IU/mL, or HBsAg Loss. HBsAg loss is defined as HBsAg less than (\<) lower limit of quantification (LLOQ) at 2 sequential visits.
Time frame: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Who Achieve Functional Cure
Functional cure is defined as sustained suppression (24 weeks or longer) of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) (\<LLOQ) off all HBV treatment and loss of HBsAg (HBsAg \< LLOQ at 2 sequential visits) with or without hepatitis B surface antibody (HBsAb) after a finite duration of therapy.
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Clinical Relapse
Clinical relapse is defined as HBsAg \>= Lower limit of Quantification (LLOQ) and HBV Deoxyribonucleic Acid (DNA) \>2000 IU/mL and Alanine Aminotransferase (ALT) \>2x Upper Limit of Normal (ULN) at 2 sequential visits.
Time frame: From B-Well Week 72 assessment up to Month 48
Change From Week 72 Baseline in Hepatitis B Quality of Life Questionnaire (HBQoL) Score
HBQoL has been designed to assess quality of life in participants with hepatitis B. It consists of 31 items and 6 domains: psychological well-being, anticipation anxiety, vitality, stigma, transmissibility and vulnerability. Response options range from 1 to 5 with higher scores indicating more severe impact of hepatitis B.
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Healthcare Resource Utilization (HCRU)
HCRU includes hospitalizations, emergency department visits, outpatient visits, specialist consultations, and liver-related interventions
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Hepatic Disease Progression Outcomes
Hepatic disease progression outcomes will include cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related mortality, all-cause mortality.
Time frame: From B-Well Week 72 assessment up to Month 48
No study locations are listed for this record.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
Of 63 phase 4 interventional studies under Hepatitis B, Chronic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 64. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bepirovirsen