A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 96
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
研究概览
简要总结
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 Genotype 2 or 3 HCV-infection
- •Naive to all HCV antiviral treatment(s)
排除标准
- •Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
- •History of any other clinically significant chronic liver disease
- •A history consistent with decompensated liver disease
- •History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
- •Participation in a clinical study within 3 months prior to first dose
研究组 & 干预措施
Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
干预措施: RBV (Drug)
PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
干预措施: PEG (Drug)
PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
时间窗: Post-treatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
次要结局
- Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities(Up to 24 weeks plus 30 days following the last dose of study drug)
- Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)(Post-treatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Up to 12 Weeks)
- Change From Baseline in HCV RNA(Baseline to Week 12)
- Percentage of Participants With Virologic Failure During Treatment(Baseline up to Week 24)
- Percentage of Participants With Viral Relapse Following Treatment(Up to Post-treatment Week 24)