NCT05630807: B-Well 1

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

Active, enrolled Phase 3 Last updated 15 December 2025

What this trial tests

Phase 3 trial testing Bepirovirsen in Chronic Hepatitis B in 981 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 December 2022

Primary endpoint
11 November 2025

5 May 2026

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	981
Start date	7 December 2022
Primary completion	11 November 2025
Estimated completion	5 May 2026
Sites	177 locations across Hong Kong, Italy, Japan, Panama, Malaysia, Taiwan, Poland, South Korea

Drugs / interventions tested

• Bepirovirsen — full drug profile →
• Placebo

Conditions studied

• Chronic Hepatitis B — all drugs for Chronic Hepatitis B →
• Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Chronic Hepatitis B or Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to \[≥\] 100 international unit per milliliter \[IU/mL\] to less than or equal \[≤\]1000 IU/mL or greater than \[\>\] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nucleic acid drugs: recent progress and future perspectives.
   Sun X, Setrerrahmane S, Li C, Hu J, et al · · 2024 · cited 72× · PMID 39609384 · DOI 10.1038/s41392-024-02035-4
2. Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
   Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
3. The progress of molecules and strategies for the treatment of HBV infection.
   Pan Y, Xia H, He Y, Zeng S, et al · · 2023 · cited 33× · PMID 37009498 · DOI 10.3389/fcimb.2023.1128807
4. Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
   Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f
5. Opportunities and challenges for hepatitis B cure.
   Roca Suarez AA, Zoulim F. · · 2023 · cited 9× · PMID 39944004 · DOI 10.1136/egastro-2023-100021
6. Evolution of antisense oligonucleotides: navigating nucleic acid chemistry and delivery challenges.
   Ruchi R, Raman GM, Kumar V, Bahal R. · · 2025 · cited 9× · PMID 39653607 · DOI 10.1080/17460441.2024.2440095
7. The Progress and Evolving Trends in Nucleic-Acid-Based Therapies.
   Liu Y, Wang C, Fu X, Ren M. · · 2025 · cited 6× · PMID 40149911 · DOI 10.3390/biom15030376
8. Immunomodulation by bepirovirsen may induce killing of infected hepatocytes (B-Together study).
   Joshi S, Freudenberg JM, Singh JM, Jordan WT, et al · · 2026 · cited 3× · PMID 41042426 · DOI 10.1007/s12072-025-10917-0