An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease on Hemodialysis (GIFT-R)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of participants achieving a 12-week sustained virologic response (SVR12).
研究概览
简要总结
The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- •Hepatitis C Virus (HCV) Ribonucleic acid (RNA) greater than 10,000 IU/mL at Screening
- •Chronic HCV, Genotype (GT)1b infection
- •Treatment-naive or treatment-experienced with an interferon (IFN)-containing regimen (IFN or pegylated-IFN with or without ribavirin).
- •A fibrosis assessment test result equivalent to Metavir F0-F2.
排除标准
- •Presence of Y93H variant at Screening
- •Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab)
- •Significant liver disease with any cause other than chronic HCV infection
- •On peritoneal dialysis
- •On hemodialysis for more than 15 years
研究组 & 干预措施
Ombitasvir/paritaprevir/ritonavir (12 weeks)
Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks
干预措施: Ombitasvir/paritaprevir/ritonavir (Drug)
结局指标
主要结局
Percentage of participants achieving a 12-week sustained virologic response (SVR12).
时间窗: 12 weeks after the last dose of study drug
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (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 relapse(Up to 12 weeks after the last dose of study drug)