A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 27
- 主要终点
- Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm
概览
简要总结
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
详细描述
The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms:
Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.
Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Chronic HDV infection
- •HDV RNA \>500 IU/mL at Screening
- •ALT \>ULN at Screening
- •Willing to take or already taking HBV nucleos(t)ide therapy.
排除标准
- •Pregnant or nursing females
- •Unwilling to comply with contraception requirements during the study
- •Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- •Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- •Solid organ or bone marrow transplantation
- •Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- •Note - Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Brelovitug 900 mg
Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks
干预措施: Brelovitug 900 mg (Drug)
Brelovitug 300 mg
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
干预措施: Brelovitug 300 mg (Drug)
Delayed treatment with brelovitug 300 mg
Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks
干预措施: Delayed Treatment with Brelovitug 300mg (Drug)
结局指标
主要结局
Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm
时间窗: Week 24
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
次要结局
- Percentage of participants with treatment-emergent adverse events (TEAEs)(Up to 96 weeks)
- Percentage of participants who discontinue treatment due to an adverse event (AE)(Up to 96 weeks)
- Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND(Up to 96 Weeks)
- Percentage of participants with HDV RNA <LLOQ(Up to 96 Weeks)
- Percentage of participants with HDV RNA <LLOQ, TND(Up to 96 Weeks)
- Percentage of participants with ALT normalization(Up to 96 Weeks)
- Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ(Up to 96 Weeks)
- Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND(Up to 96 Weeks)
- Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND(Up to 96 Weeks)
- Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.(Post-Treatment Weeks 24 and 48)
- Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)(Up to 96 Weeks)
- Change from baseline in APRI (AST-to-platelet ratio index)(Up to 96 Weeks)
- Change from baseline in CTP score in participants with cirrhosis(Up to 96 Weeks)
- Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis(Up to 96 Weeks)
- Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.(Up to 96 Weeks)