Skip to main content
Eligibility
for people ages 18–115
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a study to evaluate chronic Hepatitis C Virus infection.

Official Title

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)

Details

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.

Keywords

Chronic Hepatitis C Infection Hepatitis C Genotype 4 Chronic Hepatitis Interferon-Free Hepatitis C Virus Renal Transplant Liver Transplant Hepatitis C Genotype 1 Ribavirin

Eligibility

You can join if…

Open to people ages 18–115

  1. Male or female, at least 18 years of age at the time of screening.
  2. 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.

  3. HCV IFN therapy treatment-naïve or -experienced, either pre or post liver or renal transplant.
  4. Screening HCV genotype testing indicating infection with genotype 1 or 4 HCV only.

You CAN'T join if...

  1. Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of Screening Visit.
  2. 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.
  3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  4. 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.
  5. 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.

Locations

  • 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
  • Medizinische Hochschule Hanover /ID# 123436
    Hanover, 30625, Germany
  • Hospital Univ Clinic i Provincial /ID# 90573
    Barcelona, Catalunya, 08028, Spain
  • Hospital Universitario La Fe /ID# 120947
    Valencia, 46026, Spain
  • Royal Prince Alfred Hospital /ID# 123975
    Camperdown, 2050, Australia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT01782495
Phase
Phase 2
Lead Scientist
Norah Terrault
Study Type
Interventional
Last Updated
May 1, 2017