A randomized, open-labeled study to evaluate the efficacy and safety of three experimental drugs (ABT-450, ABT-267 and ABT-333) compared with Telaprevir (a licenced product) in people with hepatitis C virus (HCV) who have previously tried and failed other treatments. Experimental means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003738-18-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Males or females 18 to 65 years old, inclusive
Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
Chronic hepatitis C, genotype 1-infection
Subject must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser
No evidence of liver cirhhosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Positive screen for drugs or alcohol
Significant sensitivity to any drug
Use of contraindicated medications within 2 weeks of dosing
Abnormal laboratory tests
Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method