A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 25
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
研究概览
简要总结
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
- •Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
- •Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
- •Participant must be documented as having no cirrhosis or compensated cirrhosis.
排除标准
- •Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
- •Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- •Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- •HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- •History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
研究组 & 干预措施
Glecaprevir/Pibrentasvir for 8 Weeks
Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.
干预措施: Glecaprevir/Pibrentasvir (Drug)
Glecaprevir/Pibrentasvir for 12 Weeks
Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.
干预措施: Glecaprevir/Pibrentasvir (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 last dose of study drug (week 20 or 24 depending on the treatment regimen)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
次要结局
- Percentage of Participants With On-treatment HCV Virologic Failure(8 or 12 weeks (depending on the treatment regimen))
- Percentage of Participants With Relapse(End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.)