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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 21
- 主要终点
- To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD
研究概览
简要总结
AT-01B-008 is a randomized, controlled, open-label, phase 3 study to compare the efficacy of a fixed dose combination of bemnifosbuvir or ruzasvir after 8 weeks in those without cirrhosis or 12 weeks in those with compensated cirrhosis of once daily treatment versus standard of care sofosbuvir or velpatasvir FDC after 12 weeks of daily treatment in subjects with chronic HCV infection. The primary objective of the study is to evaluate the efficacy of bemnifosbuvir or ruzasvir as fixed dose combination administered for 8 or 12 weeks versus sofosbuvir or velpatasvir FDC administered for 12 weeks.
Approximately 880 subjects will be randomized 1 to 1 and stratified by cirrhosis and genotype in the main study.
There will be an optional PK sub-study conducted on approximately 50 subjects who receive bemnifosbuvir or ruzasvir and provide consent to participate.
Patients in India enrolled in the trial will be given the option to participate in the PK sub study.
An independent Data Safety Monitoring Board will review safety and efficacy data during the course of the study, as described in the DSMB charter, to evaluate continued benefit or risk of subjects enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Use of adequate contraception for females of childbearing potential 2 Must be direct acting antiviral (DAA) treatment naïve (never exposed to an approved or experimental DAA for HCV) 3 Documented medical history compatible with chronic HCV 4 Either no liver cirrhosis or with compensated liver cirrhosis 5 If HIV-1-positive, must meet the following 2 criteria: i.
- •Antiretroviral (ARV) regimen for more than 8 weeks prior to screening visit, with CD4 T-cell count more than 200 cells/mm3 and plasma HIV-1 RNA less than LLOQ ii.
- •Suitable ARV treatment and not taking any contraindicated medications.
排除标准
- •1 Pregnant or breastfeeding 2 Co-infected with hepatitis B virus 3 Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator 4 Requirement of any prohibited medications 5 Use of other investigational drugs within 30 days of dosing 6 History or signs of decompensated liver disease (decompensated cirrhosis) 7 History of hepatocellular carcinoma (HCC) 8 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.
结局指标
主要结局
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD
时间窗: Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
次要结局
- To evaluate the effect of RASs in NS5A and/or NS5B on the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD(Proportion of subjects with baseline RASs in NS5A & NS5B who achieved SVR at Weeks 24 & 36)