A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Males or females between 18 and 65 years, inclusive, at time of Screening

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control

• Subject has never received antiviral treatment for hepatitis C infection

• Chronic HCV Genotype-1 infection prior to study enrollment

Exclusion Criteria:

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab)

• Females who are pregnant or plan to become pregnant, or breastfeeding

• Any current or past clinical evidence of cirrhosis

• Screening laboratory analyses that showing abnormal laboratory results

• Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV

• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol

• Positive screen for drugs or alcohol