A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
研究概览
简要总结
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- •Male and female subjects, 18 to 70 years of age, inclusive
- •Genotype 1, chronic hepatitis C with detectable HCV RNA.
- •Screening laboratory values, tests, and physical exam within acceptable ranges
- •Able and willing to follow contraception requirements
- •Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.
排除标准
- •Subject has any contraindications to Pegasys® or Copegus® therapy
- •Evidence of hepatic decompensation in cirrhotic subjects
- •History of organ transplant
- •History of, or any current medical condition which could impact the safety of the subject in participation in the study
研究组 & 干预措施
T12PR24 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: telaprevir (Drug)
T12PR24 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: ribavirin (Drug)
T12PR24 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: peginterferon alfa-2a (Biological)
T12PR48 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: telaprevir (Drug)
T12PR48 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: ribavirin (Drug)
T12PR48 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
干预措施: peginterferon alfa-2a (Biological)
T12PR48 (eRVR-)
Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
干预措施: telaprevir (Drug)
T12PR48 (eRVR-)
Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
干预措施: ribavirin (Drug)
T12PR48 (eRVR-)
Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
干预措施: peginterferon alfa-2a (Biological)
Other
Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
干预措施: telaprevir (Drug)
Other
Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
干预措施: ribavirin (Drug)
Other
Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
干预措施: peginterferon alfa-2a (Biological)
结局指标
主要结局
Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
时间窗: 24 weeks after the last planned dose of study treatment
SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification \[LLOQ\] of 25 IU/mL).
次要结局
- Proportion of Subjects Who Have Undetectable HCV RNA at Week 72(72 weeks after the last planned dose of study treatment)
- Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment(12 weeks after last dose of study treatment)
- Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12(Week 4 and Week 12)
- Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)(Week 24 or Week 48)
- Proportion of Enrolled Subjects Who Relapse(From EOT to Week 48 or Week 72)
- Proportion of Randomized Subjects Who Relapse(From EOT to Week 48 or Week 72)
- Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Week 72)