A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated 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
- EUCTR2012-003687-52-AT
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
-Males or females 18 and 70 years old, inclusive
-Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control (Note: Hormonal contraceptives, including oral, topical, injectable or implantable varieties, may not be used during administration of study drugs)
-Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 10,000 IU/mL at screening)
-Subject has never received antiviral treatment for hepatitis C infection
-No evidence of liver cirhosis
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
-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