Long-term follow-up study to evaluate durability of treatment response in previous bepirovirsen study participants (B-Sure).
EU CTIS ID: 2023-506867-33-01
What this study is testing
1. To describe long-term durability of funtional cure in not-on NA complete responders, who achieve FC 2. To describe long-term durability of functional cure following NA cessation in B-Sure, in on-NA complete responders. 3. To describe long-term durability of functional cure in NA-cessated participants who achieved FC in B-well 1 & 2
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule
- 2. Capable of giving informed consent
- 209668 (B-Clear), 209348 (B-Together) and 212602 (B-Fine) participants: 3. Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved a complete response in the parent study and who maintained a response for 24 weeks until the EoS visit in their parent study, in the absence of rescue medication (defined as complete responders to bepirovirsen from the parent study) OR b. Demonstrated HBsAg reduction from parent study Baseline with HBsAg levels and HBV DNA for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
- 202009 and 219288 (B-Well 1 & 2) participants: 4. Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where approrpiate) AND a. NA cessated at Week 48 in parent study and achieved HBsAg and HBV DNA, in the absence of rescue medication at the EOS visit (Week 96) in the parent study OR b. Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining HBsAg and HBV DNA at EOS visit (Week 72) of parent study OR c. Did not achieve NA cessation criteria in parent study, but achieved HBsAg and HBV DNA at EOS visit (Week 72) of parent study
- 217023 (TH HBV ASO-001) participants: 5. Participants who have previously received at least 1 dose of bepirovirsen AND achieved HBsAg and HBV DNA at the EOS study visit in parent study
You likely can't join if
- 1. Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
- 2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study
The study team makes the final eligibility decision.
Where it's taking place
- Panama
- Philippines
- Brazil
- United Kingdom
- Thailand
- Turkey
- Canada
- Australia
- Hong Kong
- Malaysia
- China
- Argentina
- Japan
- Taiwan
- Korea, Republic of
- South Africa
- India
- Singapore
- Russian Federation
- United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama; Philippines; Brazil; United Kingdom; Thailand; Turkey and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.