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: 14.1 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-FR
- 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 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 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 <br> Secondary end point(s): The secondary endpoints are: <br> 1. The percentage of subjects with rapid virologic response (HCV RNA < LLOQ at Week 4);<br> 2. The percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment)<br> 3. The comparison of the percentage of subjects with SVR12 between<br> the two arms.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. 4 weeks after the first dose of study drug;<br> 2. 12 or 24 weeks after the first dose of study drug.<br> 3. 12 weeks after the last dose of study drug for the 12 week<br> arm and 24 weeks after the last dose of study drug for the 24 week arm.<br>