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+/-RBV in Treating Subjects With Genotype 2,4,5 and 6 Chronic Hep C Infection

Merck Sharp & Dohme Corp.0 sites100 target enrollmentAugust 2, 2013

ConditionsHepatitis C Virus Genotype 2, 4, 5 and 6 MedDRA version: 16.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 16.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsRebetol

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C Virus Genotype 2, 4, 5 and 6
Sponsor: Merck Sharp & Dohme Corp.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp.

Eligibility Criteria

Inclusion Criteria

•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 at least 18 years of age on day of signing informed consent.
•2\. have a body weight above 50 kg (111 lbs) and below 125 kg (275 lbs).
•3\. For Part A only: have Chronic Hepatitis C Virus infection; specifically genotype 2\. The amino acid variant at position 31 in the NS5A region must be documented prior to enrollment of the study.
•For Part B only: have chronic Hepatitis C virus GT2 or GT4, or GT5 or GT6 infection.
•\- Positive for antiHCV antibody, HCV RNA or an HCV genotype at least 6 months before screening and positive for HCV RNA more than 10,000 IU/mL in blood at the time of screening.
•\- Absences of ascites, bleeding esophageal varices, hepatic encephalopathy or other signs or symptoms of advanced liver disease or cirrhosis.
•4\. absence of cirrhosis, defined as any one of the following:
•\- Liver biopsy performed within 2 years of day 1 of this study showing absence of cirrhosis.

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•The following criteria apply to both Part A and Part B (unless specified otherwise)
•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 study 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 Part A: has non genotype 2 Hepatitis C Virus infection, including a mixed GT infection or a non\-typeable genotype.
•For Part B: has HCV infection with a genotype other than GT2, GT4, GT5 or GT6, including a mixed GT infection or infection with nontypeable genotype.
•3\. is not treatment naïve (has previously received treatment for Hepatitis C).
•4\. proven to be coinfected with hepatitis B or HIV.
•5\. 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).
•6\. has a clinical diagnosis of substance abuse.
•7\. has evidence of active or suspected malignancy (cancer), or a history of malignancy, within the last 5 years. Subjects under evaluation for malignancy are not eligible.