An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon ?-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous Abbott DAA Combination Study

Abbott GmbH & Co. KG0 个研究点目标入组 120 人开始时间: 2012年6月1日最近更新: 2017年7月3日

适应症

试验速览

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•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

•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.

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