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 not had treatment before. Experimental means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003754-84-HU
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 314
1. Male or female and age is 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
2. Subject has never received antiviral treatment for hepatitis C infection.
3. Chronic HCV Genotype-1 infection prior to study enrollment.
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 314
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
2. Positive screen for drugs or alcohol.
3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
4. Females who are pregnant or plan to become pregnant, or breastfeeding
5. Any current or past clinical evidence of cirrhosis
6. Screening laboratory analyses that showing abnormal laboratory results
7. Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for Telaprevir, PegIFN and RBV
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