A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 73
- 主要终点
- Percentage of participants with a composite endpoint
研究概览
简要总结
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
详细描述
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:
- Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
- Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
- Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.
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 —（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.
- •Abnormal ALT (>upper limit of normal) 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
- •Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- •Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- •Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Brelovitug 300mg
Dose - brelovitug 300 mg Frequency- once weekly
干预措施: Brelovitug 300 mg (Drug)
Brelovitug 900mg
Dose - brelovitug 900 mg Frequency- once every 4 weeks
干预措施: Brelovitug 900 mg (Drug)
Delayed Treatment with brelovitug 300mg
Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly
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
时间窗: Week 24
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
次要结局
- Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS(Weeks 24, 48, 96, and 120, if applicable)
- Percentage of participants that achieve that achieve virologic response and ALT normalization(Weeks 24, 48, 96, and 120, if applicable)
- Percentage of participants with a composite endpoint by treatment regimen(Weeks 24, 48, 96, and 120, if applicable)
- Percentage of participants with HDV associated liver disease progression(Weeks 24, 48, 96, and 120, if applicable)