A randomized, open-label study to evaluate the safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in people with Genotype 1 hepatitis C Virus (HCV) and early liver damage. Experimental means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C Infection and compensated cirrhosisMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003088-23-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 300
-Males or females 18 - 70 years old, inclusive
-Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
-Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening
-Subject has either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond
-Documentation of cirrhosis (Child Pugh A)
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
-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