A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 39
- 主要终点
- HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
研究概览
简要总结
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
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
- •HDV RNA ≥ 500 IU/mL at screening
- •Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- •Noncirrhotic or compensated cirrhotic liver disease at screening
- •On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy
排除标准
- •Serum ALT ≥ 5 × ULN
- •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
- •Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
研究组 & 干预措施
Arm 1
Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
干预措施: Tobevibart (Drug)
Arm 1
Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
干预措施: Elebsiran (Drug)
Arm 2
Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
干预措施: Tobevibart (Drug)
Arm 2
Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
干预措施: Bulevirtide (Drug)
Arm 2
Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 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) at Week 24
时间窗: Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
时间窗: 24 Weeks after End of Treatment
次要结局
- Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240(Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240)
- HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240(Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240)
- Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240(Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240)