A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 28
- 主要终点
- Proportion of participants with HBsAg loss at end of treatment
研究概览
简要总结
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-
- •Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m
- •Chronic HBV infection for ≥ 6 months.
- •On NRTI therapy for at least 6 months.
排除标准
- •Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
- •Significant liver fibrosis or cirrhosis.
- •History or evidence of drug or alcohol abuse.
- •History of intolerance to SC injection.
- •History of chronic liver disease from any cause other than chronic HBV infection.
- •History of hepatic decompensation.
- •Contraindications to the use of Peg-IFNα.
研究组 & 干预措施
Cohort 3
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
干预措施: PEG-IFNα (Biological)
Cohort 3
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
干预措施: BRII-835 (Drug)
Cohort 1
Participants will receive multiple doses of PEG-IFNα for 48 weeks.
干预措施: PEG-IFNα (Biological)
Cohort 2
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
干预措施: PEG-IFNα (Biological)
Cohort 2
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
干预措施: BRII-835 (Drug)
Cohort 4
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).
干预措施: PEG-IFNα (Biological)
Cohort 4
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort).
干预措施: BRII-835 (Drug)
结局指标
主要结局
Proportion of participants with HBsAg loss at end of treatment
时间窗: Up to Week 48
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
时间窗: Up to Week 72
Proportion of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to Week 72
Proportion of participants with serious adverse events (SAEs)
时间窗: Up to Week 72
次要结局
未报告次要终点