A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care 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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese participant diagnosed with compensated CHC GT 1
- •Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
- •Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
- •No evidence of cirrhosis
排除标准
- •Co-infection with human immunodeficiency virus (HIV)
- •Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
- •Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
- •Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant
研究组 & 干预措施
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: vaniprevir (Drug)
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: peg-IFN (Biological)
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: ribavirin (Drug)
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: vaniprevir (Drug)
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: peg-IFN (Biological)
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
干预措施: ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
时间窗: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
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 the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Percentage of Participants Who Discontinued Study Drug Due to an AE
时间窗: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
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 the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
时间窗: 24 weeks after 24 weeks of study therapy (up to 48 weeks)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
次要结局
- Percentage of Participants Achieving SVR12(12 weeks after 24 weeks of study therapy (up to 36 weeks))
- Percentage of Participants Achieving Complete Early Virologic Response (cEVR)(At Week 12)
- Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)(At Week 24)
- Percentage of Participants Achieving Rapid Virologic Response (RVR)(At Week 4)
- Mean Change From Baseline in HCV RNA (Log 10)(Baseline, Week 2, Week 4, Week 8, Week 12, Week 24)