A study to evaluate the safety and effect of treatment with experimentalantiviral drugs in combination with peginterferon a-2a and ribavirin inpeople with hepatitis C virus who did not respond to treatment in aprevious Abbott combination study.
- Conditions
- Chronic Hepatitis C infection.MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005393-32-IT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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 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) while receiving study drug and for 6 months (or per local ribavirin label) after stopping study drug, unless abstinent from sexual intercourse. Females are considered of hildbearing 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 a folliclestimulating hormone [FSH] level indicating a postmenopausal state), or ? Surgically sterile (defined as history of bilateral tubal ligation, bilateral XML File Identifier: XygKg/iSqRmdRsaKKUjCUNCrMJY= Page 26/36 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 6 months (or per local ribavirin label) after the last dose of study drug, unless abstinent from sexual intercourse. 4. Subject must be considered an appropriate candidate for pegIFN, RBV, ABT-450/r and ABT-267 therapy in the opinion of the investigator. 5. Subject is infected with HCV genotype 1 at screening.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 (at the time of enrollment into the previous Abbott DAA combination 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; NS5A 28, 29, 30, 31, 32, 58, or 93. 2. Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant. 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 1 month prior to study drug administration. 4. Use of any medications contraindicated for use with pegIFN, RBV or ritonavir within 2 weeks prior to study drug administration or 10 halflives, whichever is longer. Prior to entering the study, subjects must be able to safely discontinue the contraindicated medication or switch to an acceptable alternative under supervision of the investigator. 5. Discontinuation of antiviral therapy due to intolerance or a DAA or RBV associated adverse event in a previous Abbott DAA combination study.
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