Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma

AbbVie Deutschland GmbH & Co. KG0 sites3 target enrollmentJuly 31, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2015

End Date

December 29, 2016

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Main Inclusion:
•1\. Male or female, at least 18 years of age at time of screening.
•2\. Chronic HCV infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection.
•3\. Early stage HCC diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
•4\. Compensated cirrhosis defined as a Child\-Pugh score of 5 or 6 at Screening.
•5\. Documented complete response to HCC treatment.
•6\. Females must be post\-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Main Exclusion:
•1\. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in subjects receiving OBV/PTV/r with and without DSV, strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8\) in subjects receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half\-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2\-DAA and 3\-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
•2\. Positive test result for hepatitis B surface antigen (HBsAg) or anti\-human immunodeficiency virus antibody (HIV Ab).
•3\. Patients not eligible for liver transplantation due to significant cardio vascular or pulmonary disease.
•4\. Clinically significant abnormalities, other than HCV infection, in a subject with HCC based upon the 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.