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 300 人开始时间: 2014年4月17日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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
•- You have received at least one dose of MK-5172 in combination with MK-8742 as detailed in
•- You understand the study procedures, alternative treatments available, risks involved with the
•study, and voluntarily agree to participate by giving written informed consent.
•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

•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 NRTI 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.
•- You are mentally or legally incapacitated, have significant emotional problems at the time of
•pre-study screening visit or expected during the conduct of the study or have a history
•of a clinically significant psychiatric disorder which, in the opinion of the
•investigator, would interfere with the study procedures.
•- You have a medical condition or personal circumstance which, in the opinion of
•the investigator and/or Sponsor, places you at unnecessary risk through
•continued participation in the trial or does not allow you to adhere to the
•requirements of the protocol.

发起方

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