A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study
A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study
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.
Inclusion criteria:
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
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
For participants rolling over from 217023 (TH HBV ASO-001):
Participants who have previously received at least 1 dose of bepirovirsen AND
Exclusion Criteria:
Pokfulam, Hong Kong
Kanchan Bagh Hyderabad, 40000, India
Hokkaido, 006-0811, Japan
Craiova Dolj, 417307, Romania
Ansan-si Gyenggi-do, 15355, South Korea
HebrOn, 08035, Spain
Taipei County, 104, Taiwan
Kho Hong Hat Yai, 90110, Thailand