QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 32
- 主要终点
- Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
研究概览
简要总结
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).
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
- Triple (Participant, Care Provider, Investigator)
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 HCV-infection
- •Naive to all HCV antiviral treatment
- •Otherwise healthy patients
排除标准
- •Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- •History of any other clinically significant chronic liver disease
- •Medical history which the investigator considers the patient unsuitable for the study
研究组 & 干预措施
SOF+RBV 12 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
干预措施: Sofosbuvir (Drug)
SOF+RBV 12 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
干预措施: RBV (Drug)
SOF+RBV 24 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
干预措施: Sofosbuvir (Drug)
SOF+RBV 24 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
干预措施: RBV (Drug)
GS-0938 Alone
Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
干预措施: GS-0938 (Drug)
GS-0938 Alone
Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
干预措施: Placebo to match sofosbuvir (Drug)
GS-0938+SOF
Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
干预措施: Sofosbuvir (Drug)
GS-0938+SOF
Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
干预措施: GS-0938 (Drug)
GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
干预措施: Sofosbuvir (Drug)
GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
干预措施: GS-0938 (Drug)
GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
干预措施: RBV (Drug)
Placebo
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
干预措施: Placebo to match sofosbuvir (Drug)
Placebo
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
干预措施: Placebo to match GS-0938 (Drug)
Retreatment Group - SOF+RBV 24 Weeks
After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
干预措施: Sofosbuvir (Drug)
Retreatment Group - SOF+RBV 24 Weeks
After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
时间窗: Post-treatment Week 12
SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
次要结局
- Percentage of Participants Who Experienced Adverse Events(Baseline to Week 24 plus 30 days)
- Change from baseline in HCV RNA(Baseline to Week 12)
- Percentage of Participants Who Developed Resistance to Sofosbuvir(Baseline to Week 24)
- Percentage of Participants With ALT Normalization(Baseline to post-treatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ during treatment(Baseline to Week 12)
- Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)(Post-treatment Weeks 4 and 24)