Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antiviral Agents; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Males and females with documented genotype 1, chronic hepatitis C infection.

• Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.

• Has not received prior antiviral treatment for HCV.

• Written informed consent by participant.

Exclusion Criteria:

• Pregnant or breastfeeding.

• Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).