This is a study to evaluate chronic Hepatitis C Virus infection.
Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I)
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir, ABT-267 (ABT-450/r/ABT-267) with or without ABT-333 and with or without ribavirin in adult transplant recipients with hepatitis C virus (HCV) infection.
Chronic Hepatitis C InfectionHepatitis C Genotype 4Chronic HepatitisInterferon-FreeHepatitis C VirusRenal TransplantLiver TransplantHepatitis C Genotype 1Ribavirin
You can join if…
Open to people ages 18–115
Male or female, at least 18 years of age at the time of screening.
Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine.
Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day.
HCV IFN therapy treatment-naïve or -experienced, either pre or post liver or renal transplant.
Screening HCV genotype testing indicating infection with genotype 1 or 4 HCV only.
You CAN'T join if...
Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
Use of any medications listed below as well as those that are contraindicated for use with either ritonavir or RBV within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer.
Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein.
Clinically significant abnormalities, other than HCV infection, in a subject post-transplant 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.
University of California, San Francisco /ID# 90538 San Francisco, California, 94143, United States
Mayo Clinic Arizona /ID# 90539 Phoenix, Arizona, 85054, United States
University of Colorado Cancer Center /ID# 90535 Aurora, Colorado, 80045, United States
The Liver Institute at Methodist Dallas Medical Ctr /ID# 90537 Dallas, Texas, 75203, United States
Baylor University Medical Center /ID# 96250 Dallas, Texas, 75246, United States
Northwestern University /ID# 90562 Chicago, Illinois, 60611, United States
The University of Chicago Medical Center /ID# 90563 Chicago, Illinois, 60637, United States
Indiana University /ID# 90536 Indianapolis, Indiana, 46202, United States
Henry Ford Health System /ID# 125419 Detroit, Michigan, 48202, United States
Columbia University Medical Center /ID# 90533 New York, New York, 10032, United States
Lahey Clinic Hospital and Medical Center /ID# 100055 Burlington, Massachusetts, 01805, United States
Hospital Auxilio Mutuo /ID# 147704 San Juan, 00918, Puerto Rico
King's College Hospital /ID# 123355 London, SE5 9RS, United Kingdom
Hopital Paul Brousse /ID# 123435 Villejuif, 94804, France