NCT00895882撤回2 期
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
研究概览
简要总结
This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.
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 HCV infection
- •Patient has had a liver biopsy without evidence of cirrhosis
- •Patient has had an eye exam prior to the start of study
- •Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study
排除标准
- •Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
- •Female patient is pregnant or breastfeeding
- •Patient has chronic hepatitis not caused by HCV
- •Patient has evidence of cirrhosis of the liver
- •Patient has HIV
- •Patient has active hepatitis B infection
- •Patient has non-genotype 1 HCV infection
- •Patient consumes excessive amounts of alcohol
研究组 & 干预措施
1
Experimental
vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks
干预措施: vaniprevir (MK7009) (Drug)
2
Experimental
vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks
干预措施: vaniprevir (MK7009) (Drug)
结局指标
主要结局
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
时间窗: 24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data
时间窗: 72 Weeks
次要结局
- 1) Proportion of patients achieving SVR24 in Treatment Regimen 5(1) 24 weeks after end of study therapy)
研究者
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