Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 30 人开始时间: 2013年3月5日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•1. Male or female between the ages of 18 and 70 years, inclusive, at time of enrollment.
•2. Liver transplantation as a consequence of HCV infection no less than 12 months before the Screening Visit.
•3. A liver biopsy which shows evidence of fibrosis ? F2 (Metavir scale) within 3 months prior to or during the Screening Period.
•4. Screening laboratory result indicating HCV genotype 1 infection.
•5. Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine where doses of immunosuppressant drugs have not been increased over the 3 months prior to Screening and no new drugs have been added for at least 3 months before Screening. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 5 mg/day.
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
•- Clinically significant abnormalities, other than HCV infection in a subject post transplant, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
•- Recent (within 6 months prior to study drugs administration) history of drug or alcohol abuse that, in the opinion of the investigator, could preclude adherence to the protocol.
•- Previous use of any investigational or commercially available anti-HCV agent other than IFN-based therapy, i.e. conventional (c)IFN and/or pegylated (Peg) IFN, with or without RBV, including previous exposure to ABT-450, ABT-333 or ABT-267.

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