B-Fine
41 evidence topics · 5 sources
Objective
Mechanistic rationale
Questions the mechanistic investigation addresses
Location and study date
Registry record: identifiers, dates, enrollment, and locations
| Field | Quoted record |
|---|---|
| Other study identifier | “212602” |
| Study start (actual) | “2020-10-06” |
| Primary completion (actual) | “2023-11-30” |
| Enrollment (actual) | “12” |
| Number of listed locations | “This study has 4 locations” |
| Results first posted | “2024-12-19” |
Countries of the listed sites
“Boston, Massachusetts, United States, 02114” (opens the source at this quote in a new tab)
“Toronto, Ontario, Canada, M5G 2C4” (opens the source at this quote in a new tab)
“Rotterdam, Netherlands, 3015 GD” (opens the source at this quote in a new tab)
“London, United Kingdom, E1 1BB” (opens the source at this quote in a new tab)
Regulatory identifiers and protocol approval date
Study design
Phase IIa, multicentre, open-label, single-arm design with repeat liver fine needle aspiration
Study duration and visit frequency
Registered design details
| Field | Quoted record |
|---|---|
| Allocation | “N/A” |
| Interventional model | “Single Group Assignment” |
| Model description | “A single arm, multi-center, open label exploratory study.” |
| Masking | “None (Open Label)” |
Eligibility criteria
Rationale for enrolling HBeAg-negative participants on NA therapy
Treatment
Bepirovirsen dose, loading doses, and duration
Study outcomes
Rationale for using HBsAg below the lower limit of quantitation by week 12 as the primary endpoint
Primary endpoint and estimation approach
HBsAg loss as the treatment endpoint in chronic hepatitis B
Rationale from the phase 2a study for a longer treatment duration
Secondary endpoints: sustained HBsAg response and sustained virologic response
Statistical analysis description
Number of participants (Planned and analyzed)
Bayesian operating characteristics for 20 participants
Conditions for increasing the sample size
Description of analysis sets
Protocol analysis sets
| Analysis set | Quoted description |
|---|---|
| Intent to Treat (ITT) | “All participants who received at least one dose of study treatment” |
| Pharmacokinetic (PK) | “All participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values)” |
| Pharmacodynamic (PD) | “All participants in the Safety population for whom a Pharmacodynamic sample was obtained and analyzed.” |
| Analysis set for primary estimand | “All Intent to Treat Participants including all observations on and off treatment.” |
Handling of intercurrent events and immunomodulator use
Primary analysis: point estimate with 95% credible interval
Results
Participant disposition
Registry participant flow
| Disposition | Bepirovirsen 300 mg |
|---|---|
| Started | “12” |
| Completed | “11” |
| Not completed | “1” |
| Reason not completed | “Withdrawal by Subject” |
Baseline characteristics
Sex and race reported only as a de-identified category
Efficacy results
Primary and sustained response endpoints
| Endpoint | Participants analyzed | Percentage of participants |
|---|---|---|
| HBsAg <LLOQ up to Week 12 (primary) | “12” | “25” |
| Sustained HBsAg response for 24 weeks after planned end of treatment | “12” | “8” |
| Sustained HBsAg response for 24 weeks after actual end of treatment | “12” | “8” |
| Sustained virologic response for 24 weeks after planned end of treatment | “12” | “8” |
| Sustained virologic response for 24 weeks after actual end of treatment | “12” | “8” |
Intrahepatic and peripheral immunophenotyping presented at AASLD 2025
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Mortality, serious adverse events, and other adverse events
| Event | Affected / at risk (%) |
|---|---|
| All-cause mortality | “0/12 (0.00%)” |
| Serious adverse events, total | “0/12 (0.00%)” |
| Other adverse events, total | “11/12 (91.67%)” |
| Injection site erythema | “7/12 (58.33%)” |
| Injection site pruritus | “4/12 (33.33%)” |
| Procedural pain | “3/12 (25.00%)” |
| Injection site pain | “2/12 (16.67%)” |
| Pyrexia | “2/12 (16.67%)” |
| Fatigue | “2/12 (16.67%)” |
| Headache | “2/12 (16.67%)” |
| Alanine aminotransferase increased | “1/12 (8.33%)” |
| Hypertransaminasaemia | “1/12 (8.33%)” |
| Platelet count decreased | “1/12 (8.33%)” |
| Creatinine renal clearance decreased | “1/12 (8.33%)” |
Study limitations
Summary: study limitations
B-Fine was an open-label study without a control group: all 12 enrolled participants received bepirovirsen 300 mg, against a planned enrollment of approximately 20, and 11 completed. Enrollment was restricted to HBeAg-negative participants on stable NA therapy in order to “enrich for potential responders”, and treatment lasted 12 weeks, while the approved label sets a maximum recommended treatment duration of 24 weeks. The protocol's operating criterion was at least 12 of 20 participants (60%) reaching HBsAg below the LLOQ by week 12; the registry reports 25% for the primary endpoint and 8% for sustained HBsAg response 24 weeks after treatment. Sex and race were reported only as a de-identified category, and the intrahepatic immunophenotyping results are described in the GSK AASLD 2025 release only by poster titles.