A Phase III Randomized 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, 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 301 人开始时间: 2014年4月2日最近更新: 2020年3月30日

适应症

试验速览

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•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 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•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.

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,