A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 in people with HCV. Experimental means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005740-95-AT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
1. Male or female and is between 18 and 70 years, inclusive, at time of screening.
2. Subject failed previous treatment with pegIFN and RBV
3. Chronic HCV genotype 1b-infection for at least 6 months prior to study Screening
4. Subject's HCV genotype is subgenotype 1b at Screening without co-infection with any other genotype/subgenotype.
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 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Recent history of drug or alcohol abuse
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-HIV antibodies (anti-HIV Ab).
3. Any current or past clinical evidence of cirrhosis
4. Any cause of liver disease other than chronic HCV infection.
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