A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Percentage of Participants Achieving RVR
研究概览
简要总结
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has chronic Genotype 1 Hepatitis C infection
排除标准
- •Subject has been previously treated for HCV
- •Has Human Immunodeficiency Virus (HIV)
- •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 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Ribavirin (Drug)
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Vaniprevir (Drug)
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Ribavirin (Drug)
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Vaniprevir (Drug)
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Pegylated-Interferon (Peg-IFN) (Drug)
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Pegylated-Interferon (Peg-IFN) (Drug)
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Pegylated-Interferon (Peg-IFN) (Drug)
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Pegylated-Interferon (Peg-IFN) (Drug)
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Pegylated-Interferon (Peg-IFN) (Drug)
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: placebo (Drug)
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Ribavirin (Drug)
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Vaniprevir (Drug)
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Ribavirin (Drug)
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Ribavirin (Drug)
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
干预措施: Comparator: Vaniprevir (Drug)
结局指标
主要结局
Percentage of Participants Achieving RVR
时间窗: Week 4
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Number of Participants Discontinuing From Study Therapy Due to AEs
时间窗: Day 1 to Day 28
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to Day 42
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
次要结局
- Number of Participants With ≥2-log10 Decrease in HCV RNA(Baseline and Week 4)
- Number of Participants With ≥3-log10 Decrease in HCV RNA(Baseline and Week 4)
- Mean Log Change From Baseline in HCV RNA(Baseline and Week 4)