Chronic Hepatitis C infection MedDRA version: 18.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ABT-450
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ABT-450
Concentration unit: mg milligram(s)
Concentr
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled in this protocol, subjects must meet all of the following inclusion criteria: 1. Subject must have experienced virologic failure as defined in a previous pegIFN-free AbbVie/Abbott DAA combination trial. 2. Female subjects of childbearing potential must be willing to use two effective forms of birth control (not including oral contraceptives or contraceptives containing ethinyl estradiol or depo progesterone) while receiving study drug and for 7 months (or per local ribavirin label) after stopping study drug, unless abstinent from sexual intercourse. Females are considered of childbearing potential unless they are either: -Post menopausal for at least 2 years (defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by follicle-stimulating hormone [FSH] level indicating a postmenopausal state), or -Surgically sterile (defined as history of bilateral tubal ligation, bilateral oophorectomy or hysterectomy). 3. Males must be surgically sterile or agree to practice two effective forms of birth control throughout the course of the study, starting with Study Day 1 and for 7 months (or per local ribavirin label) after the last dose of study drug, unless abstinent from sexual intercourse. 4. For Cirrhotic subjects, compensated cirrhosis defined as Child-Pugh score of = 6 at screening. 5. Subject is infected with HCV genotype 1 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: To be enrolled in this protocol, subjects must not meet any of the following exclusion criteria: 1. In subjects with a null or partial response to pegIFN/RBV treatment (With or without approved DAAs) at any time prior to pre-screening for this study, the presence of variants relative to the appropriate prototypic reference sequence (H77 for 1a or Con1 for 1b) at any of the following amino acid positions: NS3 protease 155, 156, or 168; or NS5A 28, 29, 30, 31, 32, 58, or 93. 2. Females who are pregnant or plan to become pregnant, or are breast-feeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV. 3. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort) of CYP3A and OATP1B1 (e.g., cyclosporine) within 2 weeks prior to study drug administration. 4. Use of any medications contraindicated for use with ABT-450, ABT-267, pegIFN, RBV or ritonavir within 2 weeks prior to study drug administration. 5. Discontinuation of antiviral therapy due to intolerance or a DAA or RBV associated adverse event in a previous AbbVie/Abbott DAA combination study (excluding intolerance or AEs associated with telaprevir).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study drug). ;Primary end point(s): The primary efficacy endpoint is the percentage of subjects with sustained virologic response 12 weeks after the last actual dose of study drug (including DAA, pegIFN, and RBV) (SVR12actual; HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). The percentage of subjects with SVR12actual and the corresponding 95% exact binomial confidence interval will be calculated overall and by treatment group in the prior study;Timepoint(s) of evaluation of this end point: 12 weeks after the last dose of study drug; Secondary Objective: ? to evaluate the percentage of subjects with sustained virologic response 24 weeks post-dosing (SVR24; HCV RNA < LLOQ 24 weeks after the last dose of study drug) and ? to evaluate the percentage of subjects with extended rapid virologic response (eRVR) (HCV RNA < LLOQ at Weeks 4 through 12 of therapy with ABT 450/r plus ABT-267 plus pegIFN plus RBV). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are the percentage of subjects with sustained virologic response 24 weeks after the last actual dose of study drug (including DAA, pegIFN, and RBV) (SVR24actual; HCV RNA < LLOQ 24 weeks after the last actual dose of study drug) and the percentage of subjects with eRVR (HCV RNA < LLOQ at TI Weeks 4 through 12). The percentage of subjects with SVR24actual and eRVR and the corresponding 95% exact binomial confidence intervals will be calculated overall and by treatment group in the prior study. ;Timepoint(s) of evaluation of this end point: 24 weeks after the last dose of study drug | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed