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 cirrhosis.MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003088-23-IT
- Lead Sponsor
- ABBOTT GMBH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 381
-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 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: 0
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 Primary end point(s): The primary efficacy endpoint is the percentage of subjects with SVR12.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug.;Main Objective: The primary objectives of this study are to assess efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) and safety of coformulated ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 12 or 24 weeks in HCV genotype 1-infected adults with compensated cirrhosis.;Secondary Objective: The secondary objectives of this study are to assess the rapid virologic response rate (RVR) (the percentage of subjects with HCV RNA < LLOQ at Week 4), the end of treatment response (EOTR) rate (the percentage of subjects with HCV RNA < LLOQ at Week 12 for the 12-week arm or at Week 24 for the 24-week arm) and compare SVR12 between the two arms.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. The percentage of subjects with rapid virologic response (HCV RNA < LLOQ at Week 4); 2. The percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment) 3. The comparison of the percentage of subjects with SVR12 between the two arms.;Timepoint(s) of evaluation of this end point: 1. 4 weeks after the first dose of study drug; 2. 12 or 24 weeks after the first dose of study drug. 3. 12 weeks after the last dose of study drug for the 12 week arm and 24 weeks after the last dose of study drug for the 24 week arm.