Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks

• Conditions: Genotype 1 Chronic Hepatitis C Infection; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001878-25-BG
• Lead Sponsor: Idenix Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-09
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Males and females with documented genotype 1, chronic hepatitis C infection.
• Subjects must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
• Written informed consent by subject.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Prior HCV treatment.
• Pregnant or breastfeeding.
• Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen (HBsAg) positive) and/or human immunodeficiency virus (HIV).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified