EUCTR2014-000824-12-ES进行中（未招募）不适用
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1. Be > or = to 18 years of age on day of signing informed consent.
- •2. HCV RNA (> or = to 10,000 IU/mL in peripheral blood) at the time of screening.
- •3. Have documented chronic HCV GT1, GT4, GT5 or GT6
- •4. Have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis
- •5. Have a previous HCV treatment status that is of non-response, partial response or treatment relapse
- •6. For HIV-1 co-infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit
- •7. For HIV-1 co-infection CD4+ T-cell count > 200 cells/mm3 at screening
- •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) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Has evidence of decompensated liver disease
- •2. Is coinfected with hepatitis B virus (e.g. HBsAg positive).
- •3. Has previous direct acting antiviral treatment.
- •4. Has signs of hepatocellular carcinoma or history of malignancy
- •5. Is taking or plans to take (a) any HIV therapy, or other medication
- •not allowed for the study
- •6. Have an exclusionary laboratory value
研究者
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