A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 381
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.
详细描述
During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.
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
- •Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- •Male or female between 18 and 70 years, inclusive, at time of Screening.
- •Chronic HCV-infection prior to study enrollment.
- •Screening laboratory result indicating HCV genotype 1-infection.
- •Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
- •Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
排除标准
- •Significant liver disease with any cause other than HCV as the primary cause
- •Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
- •Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
- •Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
- •A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
研究组 & 干预措施
ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
干预措施: ABT-450/r/ABT-267, ABT-333 (Drug)
ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
干预措施: Ribavirin (RBV) (Drug)
ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
干预措施: ABT-450/r/ABT-267, ABT-333 (Drug)
ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
干预措施: Ribavirin (RBV) (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
时间窗: 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm(12 weeks after the last actual dose of study drug)
- Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period(Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Percentage of Participants With Virologic Relapse After Treatment(within 12 weeks after the last dose of study drug)