Overview

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