Chronic Hepatitis C Infection MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female and age is between 18 and 65 years, inclusive, at time of Screening. Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control 2. Subject has never received antiviral treatment for hepatitis C infection. 3. Chronic HCV Genotype-1 infection prior to study enrollment. 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 314 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol. 2. Positive screen for drugs or alcohol. 3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab). 4. Females who are pregnant or plan to become pregnant, or breastfeeding 5. Any current or past clinical evidence of cirrhosis 6. Screening laboratory analyses that showing abnormal laboratory results 7. Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for Telaprevir, PegIFN and RBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to demonstrate that treatment with ABT-450/r/ABT-267 and ABT-333 administered with or without RBV has non-inferior efficacy (the percentage of subjects achieving SVR12, HCV RNA < LLOQ 12 weeks following treatment) compared to treatment with telaprevir and pegIFN/RBV and to compare the safety of the regimens in treatment-naive HCV genotype (GT) 1a- and 1b-infected adults without cirrhosis.;Secondary Objective: The secondary objectives of this study are to compare the following between treatment with Arm A (3 DAAs with RBV) and treatment with Arm B (telaprevir with pegIFN/RBV) within HCV subgenotype 1a, and between treatment with Arm C (3 DAAs with RBV) or D (3 DAAs without RBV), and treatment with Arm E (telaprevir with pegIFN/RBV) in HCV subgenotype 1b: ? change from baseline to the Final Treatment Visit in general health-related quality of life using the SF-36 Mental Component Summary (superiority), ? change from baseline to the Final Treatment Visit in general health-related quality of life using the SF-36 Physical Component Summary scores (superiority), ? the percentage of subjects achieving SVR12 ? the percentage of subjects with virologic failures during treatment and the percentage of subjects with relapse post-treatment.;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. QOL assessed by SF-36 instrument, 2. Percentage of subjects with SVR12 between the different treatment arms, 3. Percentage of subjects with virologic failure during treatment and with post-treatment relapse;Timepoint(s) of evaluation of this end point: 1. 12 weeks after first dose of study drug 2. 12 weeks after last dose of study drug 3. 24, 36 and 48 weeks after last dose of study drug | — |
Countries
Argentina, Brazil, Chile, Finland, Hungary, Poland, Romania, Slovakia
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed