A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection

5172-012

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

2011-11-28

2012-05-01

2012-05-01

Terminated

Early phase I

5

Inclusion Criteria: * Body weight ≥ 88 lbs and ≤ 275 lbs * Documented chronic Hepatitis C (CHC) GT2 or GT3 infection * No known cirrhosis * Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug * Chest X-ray within the last 6 months * Eye exam within the last 6 months Exclusion Criteria: * Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen) * Prior approved or investigational treatment for hepatitis C * Evidence of hepatocellular carcinoma * Diabetic and/or high blood pressure with clinically significant eye exam findings * Pre-existing psychiatric condition * Clinical diagnosis of abuse of certain substances within specified timeframes * Known medical condition that could interfere with participation * Active or suspected cancer within the last 5 years * Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs * Male who is planning to impregnate partner or donate sperm * Male with a pregnant female partner * Chronic hepatitis not caused by HCV

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-05-22