An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 主要终点
- Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.
Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.
Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.
详细描述
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
- •HCV genotype 1 infection
- •Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
排除标准
- •Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- •Discontinuation of the prior DAA treatment for reasons other than virologic failure
- •Confirmed presence of hepatocellular carcinoma
- •Abnormal lab tests
研究组 & 干预措施
3-DAA with or without SOF and RBV
3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
3-DAA with or without SOF and RBV
3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
干预措施: Sofosbuvir (Drug)
3-DAA with or without SOF and RBV
3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
时间窗: 12 weeks after the last dose of active 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 Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment(12 weeks after the last dose of active drug)
- Percentage of Participants With On-treatment Virologic Failure(Up to week 24)
- Percentage of Participants With Post-Treatment Relapse(Within 12 weeks after the last actual dose of active study drug)