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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Placebo; Drug: Ribavirin (RBV); Drug: IDX184; Biological: Peginterferon alfa-2a (Peg-IFN)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371604

IDX-08C-005 (Other Identifier)

2355-005

2011-001878-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

IDX184 50 mg + Peg-IFN/RBV

Experimental group

Description:

IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

Treatment:

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: IDX184

Drug: Ribavirin (RBV)

Drug: Placebo

IDX184 100 mg + Peg-IFN/RBV

Experimental group

Description:

IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

Treatment:

Biological: Peginterferon alfa-2a (Peg-IFN)

Drug: IDX184

Drug: Ribavirin (RBV)