An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
研究概览
简要总结
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
详细描述
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- •Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- •Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- •Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- •Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- •Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
排除标准
- •Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- •Evidence of current or past Child-Pugh B or C classification
- •Confirmed presence of hepatocellular carcinoma
- •Abnormal laboratory tests
- •Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
- •Previous treatment with a direct acting antiviral agent (DAA) containing regimen
- •History of solid organ transplant.
研究组 & 干预措施
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
干预措施: Ombitasvir/Paritaprevir/Ritonavir (Drug)
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
干预措施: Dasabuvir (Drug)
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 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 (SVR12) Post-treatment
时间窗: Post-treatment Day 1 to Post-treatment Week 12
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
次要结局
- Percentage of Participants With On-Treatment Virologic Failure(Day 1 through Week 12)
- Percentage of Participants With Post-Treatment Relapse(Post-treatment Day 1 to Post-treatment Week 12)