NCT07037277进行中（未招募）3 期
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 880
- 试验地点
- 109
- 主要终点
- Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of adequate contraception for females of childbearing potential
- •Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
- •Documented medical history compatible with chronic HCV
- •Either no liver cirrhosis or with compensated liver cirrhosis
- •If HIV-1-positive, must meet the following 2 criteria:
- •Antiretroviral (ARV) regimen for >8 weeks prior to screening visit, with CD4 T-cell count >200 cells/mm3 and plasma HIV-1 RNA <LLOQ
- •Suitable ARV treatment and not taking any contraindicated medications
排除标准
- •Pregnant or breastfeeding
- •Co-infected with hepatitis B virus
- •Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- •Prior exposure to any HCV DAA
- •Requirement of any prohibited medications
- •Use of other investigational drugs within 30 days of dosing
- •History or signs of decompensated liver disease (decompensated cirrhosis)
- •History of hepatocellular carcinoma (HCC)
- •Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
研究组 & 干预措施
Bemnifosbuvir - Ruzasvir (BEM/RZR)
Experimental
干预措施: Bemnifosbuvir-Ruzasvir (Drug)
Sofosbuvir-Velpatasvir (SOF/VEL)
Active Comparator
干预措施: Sofosbuvir-Velpatasvir (Drug)
结局指标
主要结局
Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
时间窗: Day 1 through Week 24
次要结局
- Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs(Day 1 through 12 weeks after the end of treatment)
- Proportion of subjects experiencing virologic failure as measured by HCV RNA RT-qPCR(Day 1 through Week 24)
研究者
研究点 (109)
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