A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
研究概览
简要总结
This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
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
- Double (Participant, Investigator)
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 years.
- •Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m
- •Chronic HBV infection for ≥ 6 months.
- •On NRTI therapy with HBV DNA < LLOQ for ≥ 6 months.
- •Serum ALT and AST ≤ ULN at screening visit.
排除标准
- •Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
- •Significant liver fibrosis or cirrhosis.
- •History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
- •History of hepatic decompensation.
- •Diagnosed or suspected hepatocellular carcinoma.
- •Current or past history of infection with HIV, HCV or HDV.
- •Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
- •Known history of immunological function impairment.
- •History of intolerance to intramuscular or subcutaneous injection.
研究组 & 干预措施
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
干预措施: BRII-179 (Biological)
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
干预措施: BRII-835 (VIR-2218) (Drug)
Regimen 1: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1).
干预措施: PEG-IFNα (Biological)
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
干预措施: PEG-IFNα (Biological)
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
干预措施: Placebo of BRII-179 (Drug)
Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα
Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα.
干预措施: Placebo of BRII-835 (Drug)
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
干预措施: BRII-179 (Biological)
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
干预措施: BRII-835 (VIR-2218) (Drug)
Regimen 2: BRII-179 + BRII-835 + PEG-IFNα
Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2).
干预措施: PEG-IFNα (Biological)
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
时间窗: Up to 96 weeks
The percentage of participants achieving HBsAg seroclearance.
时间窗: Up to 48 weeks
次要结局
- Percentage of participants achieving HBsAg seroclearance.(Up to 72 weeks)
- Percentage of participants achieving functional cure.(Up to 96 weeks)
- Percentage of participants achieving HBsAg seroconversion.(Up to 72 weeks)