At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bepirovirsen (drug), Placebo (drug)
- How long the study runs
- Study runs about 85 months (dates as stated)
- About the drug or intervention
- Bepirovirsen — drug: No study drug will be administered in this study. · Placebo — drug: No study drug will be administered in this study.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 360
- Started
- 2021-12-14
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for hepatitis b
- • Phase2 - 360 participants
- • This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hepatitis b
Where?
- • Cottingham - GSK Investigational Site
- • Liverpool - GSK Investigational Site
- • London - GSK Investigational Site
- • London - GSK Investigational Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with...
- ✓Capable of giving agreement to take part.
- ✓For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
- ✓Participants who have previously received at least one dose of bepirovirsen AND
- ✓Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their...
Who cannot take part
- ✗Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV...
- ✗Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in...
See the full criteria
Where Is This Study? (5 UK sites)
GSK Investigational Site
Cottingham HU16 5JQ, United Kingdom
GSK Investigational Site
Liverpool L7 8XP, United Kingdom
GSK Investigational Site
London SW9 8RR, United Kingdom
GSK Investigational Site
London WC1E 6JB, United Kingdom
GSK Investigational Site
Plymouth PL68DH, United Kingdom
