An 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 Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
研究概览
简要总结
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
- •Chronic HCV-infection prior to study enrollment.
- •Screening laboratory result indicating HCV genotype 1b-infection.
- •Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
- •Per local standard practice, documentation of cirrhosis by one of the following methods:
- •Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,
- •FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.
排除标准
- •HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
- •Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
- •Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
- •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.
- •Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
- •Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)
- •Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:
- •Hemochromatosis
- •Alpha-1 antitrypsin deficiency
- •Wilson's disease
- •Autoimmune hepatitis
- •Alcoholic liver disease
- •Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
- •Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
研究组 & 干预措施
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
干预措施: ABT-450/r/ABT-267 (Drug)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
干预措施: ABT-333 (Drug)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
干预措施: ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
时间窗: 12 weeks after last dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
时间窗: 24 weeks after last dose of study drug
SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.
次要结局
- Percentage of Participants With On Treatment Virologic Failure(Within 12 weeks after first dose of study drug)
- Percentage of Participants With Virologic Relapse(Within 12 weeks after the last dose of study drug)
- Percentage of Participants With Virologic Relapse by Post-Treatment Week 24(Within 24 weeks after the last dose of study drug)