A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 285
- 主要终点
- Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
研究概览
简要总结
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
24-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.
干预措施: Vaniprevir (Drug)
24-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.
干预措施: Pegylated Interferon (Peg-IFN) (Drug)
24-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.
干预措施: Ribavirin (RBV) (Drug)
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
干预措施: Vaniprevir (Drug)
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
干预措施: Pegylated Interferon (Peg-IFN) (Drug)
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
干预措施: Ribavirin (RBV) (Drug)
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV
Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
干预措施: Placebo (PBO) (Drug)
48-wk Vaniprevir 300 mg + Peg-IFN/RBV
Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Vaniprevir (Drug)
48-wk Vaniprevir 300 mg + Peg-IFN/RBV
Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Pegylated Interferon (Peg-IFN) (Drug)
48-wk Vaniprevir 300 mg + Peg-IFN/RBV
Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Ribavirin (RBV) (Drug)
48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Vaniprevir (Drug)
48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Pegylated Interferon (Peg-IFN) (Drug)
48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Ribavirin (RBV) (Drug)
48-wk PBO + Peg-IFN/RBV
PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Pegylated Interferon (Peg-IFN) (Drug)
48-wk PBO + Peg-IFN/RBV
PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Ribavirin (RBV) (Drug)
48-wk PBO + Peg-IFN/RBV
PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
干预措施: Placebo (PBO) (Drug)
结局指标
主要结局
Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
时间窗: Up to 72 weeks
The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to 73 weeks
The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Number of Participants Discontinuing From Study Treatment Due to AEs
时间窗: Up to 48 weeks
The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.
次要结局
- Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.(72 weeks)
- Percentage of Participants Achieving cEVR(Up to Week 60)
- Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.(Week 48)