A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
研究概览
简要总结
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18 to 70 years at screening
- •Chronic HDV infection for >/= 6 months
- •On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 20 IU/ml at screening, currently on locally approved NRTI therapy
- •Serum ALT > ULN and < 5x ULN
- •Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
排除标准
- •Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
- •History of significant liver disease from non-HBV or non-HDV etiology
- •History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
- •History of anaphylaxis
- •History of immune complex disease
- •History of autoimmune disorder
- •History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
研究组 & 干预措施
Arm 1 (Tobevibart + Elebsiran)
Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
干预措施: Tobevibart (Drug)
Arm 1 (Tobevibart + Elebsiran)
Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
干预措施: Elebsiran (Drug)
Arm 2 (Tobevibart + Elebsiran)
Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
干预措施: Tobevibart (Drug)
Arm 2 (Tobevibart + Elebsiran)
Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
干预措施: Elebsiran (Drug)
结局指标
主要结局
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
时间窗: Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
时间窗: Up to 12 weeks
次要结局
- HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2(Up to 48 weeks)