An open-label study to evaluate the safety and efficacy of three experimental drugs (Ombitasvir/ ABT-450/ Ritonavir and Dasabuvir) in people with genotype 1b 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: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-001953-18-BE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
-Males or females at least 18 years of age at time of screening
-Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than
or equal to 1,000 IU/mL at screening
-HCV genotype 1b infection confirmed at screening
-Compensated cirrhosis defined as Child Pugh A (score 5 or 6) at screening
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
-Women who are pregnant or breastfeeding
-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