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

Phase 1

• Conditions: Chronic Hepatitis C infection; MedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005393-32-BE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-24
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subject must have experienced virologic failure as defined in a previous 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) 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 a 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 Visit.

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. In subjects with a prior 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; 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 within 7 months (or per local RBV label) after their last dose of study drug/RBV.
3. Use of known inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort) of CYP3A 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).

Study & Design

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