A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Percentage of Participants Achieving Rapid Viral Response
研究概览
简要总结
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has chronic genotype 1 Hepatitis C infection
排除标准
- •Has not tolerated previous course of peg-IFN and ribavirin
- •Has Hepatitis B
- •Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin
研究组 & 干预措施
Vaniprevir 200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Vaniprevir (Drug)
Vaniprevir 200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Pegylated Interferon (peg-IFN) (Drug)
Vaniprevir 200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Ribavirin (Drug)
Vaniprevir 600 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Vaniprevir (Drug)
Vaniprevir 600 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Pegylated Interferon (peg-IFN) (Drug)
Vaniprevir 600 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Ribavirin (Drug)
Vaniprevir 1200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Vaniprevir (Drug)
Vaniprevir 1200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Pegylated Interferon (peg-IFN) (Drug)
Vaniprevir 1200 mg + peg-IFN + ribavirin
Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Ribavirin (Drug)
Placebo + peg-IFN + ribavirin
Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Pegylated Interferon (peg-IFN) (Drug)
Placebo + peg-IFN + ribavirin
Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Rapid Viral Response
时间窗: Week 4
Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was \<1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.
次要结局
- Number of Participants Who Experienced at Least One Adverse Event(Up to 6 weeks)
- Number of Participants Who Discontinued Study Drug Due to an Adverse Event(Up to 6 weeks)
- Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4(Baseline and Week 4)
- Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4(Baseline and Week 4)
- Change From Baseline in HCV RNA in log10 at Week 4(Baseline and Week 4)