A Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Participants living with Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection on Antiretroviral Treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509588-25-00

Acronym

219231

Enrollment

Registered

2025-01-15

Start date

2025-02-11

Completion date

Unknown

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

Percentage of participants achieving HBsAg not detected and HBV Deoxyribonucleic acid (DNA) less than (<) Lower limit of quantification (LLOQ) at 36 weeks after scheduled end of study treatment in absence of rescue medication

Detailed description

Percentage of participants achieving HBsAg not detected and HBV DNA

Interventions

DRUGPlacebo for Bepirovirsen Solution for Injection

DRUG150 mg/mL SSD

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants achieving HBsAg not detected and HBV Deoxyribonucleic acid (DNA) less than (<) Lower limit of quantification (LLOQ) at 36 weeks after scheduled end of study treatment in absence of rescue medication	—

Secondary

Measure	Time frame
Percentage of participants achieving HBsAg not detected and HBV DNA	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026