Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 befo...
Detailed Description
The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01854697
Start Date
March 1 2013
End Date
July 1 2015
Last Update
June 6 2018
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