An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 主要终点
- Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection at Screening.
- •Screening laboratory result indicating HCV genotype 1b infection.
- •Treatment-naïve and non-cirrhotic.
排除标准
- •HCV genotype or subtype other than GT1b.
- •Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
- •Any current or past clinical evidence of cirrhosis.
- •Screening laboratory analyses that shows abnormal results.
- •Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.
研究组 & 干预措施
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
干预措施: ombitasvir/paritaprevir/ritonavir (Drug)
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
干预措施: dasabuvir (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
次要结局
- Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12(Baseline and 12 weeks after the last actual dose of study drug)
- Percentage of Participants With On-Treatment Virologic Failure During Treatment Period(Up to 8 weeks while on treatment)
- Percentage of Participants With Post-Treatment Relapse12(Up to 12 weeks after last dose of study drug)
- Percentage of Female Participants Responding With SVR12(12 weeks after the last actual dose of study drug)