A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects with Chronic HCV GT1, 4 or 6 Infection - MK-5172/MK-8742 vs Sofosbuvir/PR in HCV GT1, 4 or 6 Infection

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 256 人开始时间: 2014年12月17日最近更新: 2016年4月18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 HCV GT1
•You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis
•Have documented chronic HCV GT 1, 4 or 6 (with no evidence of non-typeable or mixed genotype) infection:
•-Positive for anti-HCV antibody, HCV RNA, or HCV GT 1, 4 or 6 at least 6 months before screening (HCV RNA and HCV genotype must be confirmed by screening lab results), or
•-Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)
•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 226
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•You have signs of decompensated liver disease
•You are coninfected with Hepatitis B
•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 pre-existing psychiatric condition
•You have an exclusionary laboratory value
•You intend to become pregnant or plan to impregnate during the study

发起方