A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection prior to study enrollment.
- •Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
- •Absence OR presence of cirrhosis.
- •If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
排除标准
- •Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- •Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
- •Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
- •Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
- •Abnormal lab tests.
- •Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
研究组 & 干预措施
Arm A (genotype [GT]3, noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
干预措施: OBV/PTV/r (Drug)
Arm A (genotype [GT]3, noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
干预措施: Sofosbuvir (Drug)
Arm B (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
干预措施: OBV/PTV/r (Drug)
Arm B (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
干预措施: Sofosbuvir (Drug)
Arm B (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
干预措施: Ribavirin (RBV) (Drug)
Arm C (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
干预措施: OBV/PTV/r (Drug)
Arm C (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
干预措施: Sofosbuvir (Drug)
Arm C (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
干预措施: Ribavirin (RBV) (Drug)
Arm D (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
干预措施: OBV/PTV/r (Drug)
Arm D (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
干预措施: Sofosbuvir (Drug)
Arm D (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
干预措施: Ribavirin (RBV) (Drug)
Arm E (GT3, cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
干预措施: OBV/PTV/r (Drug)
Arm E (GT3, cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
干预措施: Sofosbuvir (Drug)
Arm E (GT3, cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
干预措施: Ribavirin (RBV) (Drug)
Arm F (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
干预措施: OBV/PTV/r (Drug)
Arm F (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants With On-treatment Virologic Failure(Up to Week 12)
- Percentage of Participants With Post-treatment Relapse(Up to 12 weeks after the last actual dose of active study drug)