EUCTR2014-000343-32-ES进行中（未招募）1 期
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,0 个研究点目标入组 300 人开始时间: 2014年4月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-You are greater than or equal to 18 years of age.
- •-You have chronic genotype 1, 4, 5, or 6 Hepatitis C virus.
- •-You must be on opiate substitution therapy (OST), have kept at least 80% of scheduled appointments while on OST, and not missed any scheduled appointments between screening and study entry
- •-You have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis or no cirrhosis.
- •-You are treatment naïve to all HCV treatment
- •-You may be co-infected with HIV
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-You have signs of decompensated liver disease.
- •-You are coinfected with Hepatitis B virus.
- •-You have signs of hepatocellular carcinoma or history of malignancy.
- •-You are taking or plan to take any medication not allowed for this study.
- •-You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus.
- •-You have an exclusionary laboratory value
- •-If you have HIV, you use HIV drugs other than a dual NNRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir [or dolutegravir or rilpivine]
- •-You have a history of opportunistic infection in the preceding 6 months prior to screening.
研究者
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