An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon a-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

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 250 人2012年10月15日

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注册库

who.int

开始日期

2012年10月15日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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.
•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 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 200

•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; 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.
•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.