A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon ?-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous Abbott combination study.

Phase 1

• Conditions: Chronic Hepatitis C infection; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005393-32-ES
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-01
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.
3. Females must have negative results for pregnancy test performed on a urine specimen obtained on Study Day 1 (prior to dosing).
4. 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.
5. Subject must be considered an appropriate candidate for pegIFN, RBV, ABT-450/r and ABT-267 therapy in the opinion of the investigator.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 subject's baseline sequence or to prototypic standard sequence 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 breast-feeding, 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 half-lives, 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 an adverse event in a previous Abbott DAA combination study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified