Last updated: 10/23/2026 16:30:46
A Study to Evaluate a Second Course of Bepirovirsen in Participants With Chronic Hepatitis B Virus who are Bepirovirsen Relapsers or Partial RespondersB-Possible
GSK study ID
310213
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
Official title: A Phase 3, Multi-Center, Open Label Study to Assess the Efficacy and Safety of a Second Course of Bepirovirsen in Participants With Chronic Hepatitis B Virus who Have Relapsed or had a Partial Response to an Initial Course of Bepirovirsen
Trial description: This is a 2-cohort, multi-centre study in which all participants will receive Bepirovirsen. The study will evaluate a second course of treatment in people who have recently completed a first course of Bepirovirsen as part of their usual care. Cohort 1 will include participants whose hepatitis B surface antigen (HBsAg) was undetectable at the end of their first course but later became detectable again (relapsers). Cohort 2 will include participants whose HBsAg was detectable at the end of the first course, but lower than before they started treatment (partial responders).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Cohort 1: Proportion of Relapsers Achieving Functional Cure (FC)
Timeframe: Up to 60 Weeks
Cohort 2: Proportion of Partial Responders Achieving Functional Cure
Timeframe: Up to 60 Weeks
Secondary outcomes:
Cohort 1: Proportion of Participants Achieving Functional Cure who had HBsAg less than or equal (<=)1000 international units per milliliter (IU/mL) at the Start of the First Course of Bepirovirsen
Timeframe: Up to Week 60
Cohort 2: Proportion of Participants Achieving Functional Cure who had HBsAg less than or equal (<=)1000 international units per milliliter (IU/mL) at the Start of the First Course of Bepirovirsen
Timeframe: Up to Week 60
Cohort 1: Number of Participants with Adverse Events
Timeframe: Up to Week 60
Cohort 2: Number of Participants with Adverse Events
Timeframe: Up to Week 60
Interventions:
Drug: Bepirovirsen
Enrollment:
191
Primary completion date:
2029-07-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B, Chronic
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2027 to November 2029
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Received a 24-week regimen of bepirovirsen in clinical care and did not permanently discontinue from treatment for any reason.
- Received NA background therapy for the duration of bepirovirsen treatment in clinical care, with no changes to this NA regimen planned over the duration of the study (except in accordance with the protocol)
- Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months before pre-screening, major surgery within 3 months before pre-screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings
- History of or suspected liver cirrhosis,
Inclusion and exclusion criteria
Inclusion criteria:
- Received a 24-week regimen of bepirovirsen in clinical care and did not permanently discontinue from treatment for any reason.
- Received NA background therapy for the duration of bepirovirsen treatment in clinical care, with no changes to this NA regimen planned over the duration of the study (except in accordance with the protocol)
- Capable of giving signed informed consent as described in full protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Cohort 1 only – participants who have undetectable HBsAg at the end of the first course of bepirovirsen: a detectable HBsAg level within the 24 weeks after the end of first course, that is confirmed by a second test ~1 week later
- Cohort 2 only – participants who have detectable HBsAg at the end of the first course of bepirovirsen: HBsAg <100 IU/mL and a response to the first course of bepirovirsen (>=1 log reduction in HBsAg from levels pre-first course of bepirovirsen), at their screening visit
- All participants: Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA < 90 IU/mL
Exclusion criteria:
- Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months before pre-screening, major surgery within 3 months before pre-screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings
- History of or suspected liver cirrhosis,
- Diagnosed or suspected hepatocellular carcinoma,
- History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
- History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex)
- Participants requiring anti-coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of investigation product (IP) treatment, by the discretion of the investigator. Occasional use is permitted.
- Co-infection with: a. Hepatitis C infection or participants that have been cured for <12 months at the time of screening (defined as having been Hepatitis C virus [HCV] RNA negative for <12 months) b. Human immunodeficiency virus (HIV) c. Hepatitis D virus defined as Hepatitis D virus (HDV) antibody positive
- For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25x ULN, discussion for inclusion to the study is required with the Medical Monitor g. Urine albumin to creatinine ratio (uACR) >0.3 milligrams per milligram (mg/mg) (or >300 mg/gram [g]). In the event of an uACR above this threshold, eligibility may be confirmed by a second measurement.
Laboratory results as follows: a. Alanine aminotransferase (ALT) >2x Upper Limit of Normal (ULN) b. Serum albumin <= 3.5 grams per deciliter (g/dL) c. Glomerular filtration rate (GFR) <= 60 millilitres per minute per 1.73 square meter (ml/min/1.73m^2) or > 15% decrease below pre-first course level, as calculated by the CKD-EPI formula (for Japan, JSN-CKDI equation) d. International normalized ratio (INR) >1.25 e. Platelet count <100 x 10^9/L f. Total bilirubin >1.25x ULN
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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