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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 16
- 主要终点
- A prospective, multi-centre study (B-Sure) to evaluate long term durability of
研究概览
简要总结
This is a Phase 2b, global, multi-centre, long-term follow-up study designed to assess
durability of treatment response from the parent study. Follow-up will be over a period of
up to 5 years, in participants who demonstrated a complete or partial response in a
previous bepirovirsen treatment study.
No further treatment with bepirovirsen will be administered in this study. Non-cirrhotic
participants who are controlled on stable NA therapy on study entry will be asked to
undergo NA cessation after 3 months in the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
- •Capable of giving informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
- •Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study.
结局指标
主要结局
A prospective, multi-centre study (B-Sure) to evaluate long term durability of
时间窗: 132 Weeks
treatment response in chronic hepatitis B participants with and without nucleos(t)ide
时间窗: 132 Weeks
therapy who have participated in a previous bepirovirsen treatment studyâ€
时间窗: 132 Weeks
次要结局
- To describe changes in(disease following NA cessation (in)
研究者
Dr VG Mohan Prasad
VGM Hospital