A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 54
- 主要终点
- Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
研究概览
简要总结
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic 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 - 60
- •Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2
- •Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •Significant fibrosis or cirrhosis
- •History or evidence of drug or alcohol abuse
- •History of intolerance to SC or IM injection
- •History of chronic liver disease from any cause other than chronic HBV infection
- •History of hepatic decompensation
研究组 & 干预措施
Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
干预措施: BRII-179 (VBI-2601) with IFN-α (Biological)
Cohort A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
干预措施: BRII-835 (VIR-2218) (Drug)
Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
干预措施: BRII-835 (VIR-2218) (Drug)
Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
干预措施: BRII-835 (VIR-2218) (Drug)
Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
干预措施: BRII-179 (VBI-2601) (Biological)
结局指标
主要结局
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
时间窗: up to Week 96
Number of participants with Serious Adverse Events (SAE)
时间窗: up to Week 96
Number of participants with abnormalities in clinical laboratory tests
时间窗: up to Week 96
Number of participants with Adverse Events (AE)
时间窗: up to Week 96
Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal
时间窗: Up to Week 96
Sustained HBsAg loss was defined as undetectable HBsAg \< 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal
Number of Participants With Adverse Events (AE)
时间窗: Up to Week 96
Treatment-emergent adverse events (TEAEs) were summarized for each cohort
Number of Participants With Serious Adverse Events (SAE)
时间窗: Up to Week 96
Serious adverse events (SAEs) were summarized for each cohort
Number of Participants With Abnormalities in Clinical Laboratory Tests
时间窗: Up to Week 96
Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort
次要结局
- Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44(Week 44)
- Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at Week 72(Week 72)
- Percentage of Participants With HBsAg Loss at Any Timepoint(Up to Week 72)
- Percentage of Participants With HBsAg Seroconversion at Any Timepoint(Up to Week 72)
- Change From Baseline in Serum HBsAg at Week 72(Week 72)
- Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening(Week 44)
- Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint(Up to Week 72)