A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection - MK-5172 + MK-8742 + Ribavirin in Genotype 2/4/5/6 HCV Patients

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,0 sites100 target enrollmentNovember 22, 2013

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

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

•In order to be eligible for participation in this trial, the subject must:
•The following applies to both Part A and Part B (unless specified otherwise)
•1\. be \=18 years of age on day of signing informed consent.
•2\. have a body weight \=50 kg (111 lbs) and \= 125 kg (275 lbs).
•3\. For Part A only: have chronic HCV GT2 infection. The amino acid variant at position 31 in the NS5A region must be documented prior to enrollment in the trial
•For Part B only: have chronic HCV GT2, or GT4, or GT5 or GT6 infection
•Note: For Part B of the trial, the amino acid variant at position 31 does not need to be determined prior to enrolling GT2 subjects in treatment arm 2\.
•Positive for anti\-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA (\= 10,000 IU/mL in peripheral blood) at the time of screening
•Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy or other signs or symptoms of advanced liver disease or cirrhosis
•4\. have absence of cirrhosis, which is defined as any one of the following:

•The subject must be excluded from the trial if the subject:
•1\. is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre\-study screening visit or expected during the conduct of the stuy or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures
•2\.For Pt A: has non GT2 HCV, including a mixed GT infection or infection with a non\-typeable GT.
•For Pt B: has HCV with a GT other than GT2, GT4, GT5 or GT6, including a mixed GT infection or infection with a non\-typeable GT.
•3\. is NOT treatment naïve,
•4\. is coinfected with hepatitis B virus or HIV.
•5\. has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
•6\. is taking or plans to take any of the prohibited medications listed in Sec. 5\.5 of this protocol within 2 weeks prior to day 1\.
•7\. is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject’s medical care).
•8\. has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes: