Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

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