A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 115
Updated:10/14/2017
Start Date:February 25, 2013
End Date:July 13, 2017

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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)

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

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.

Inclusion Criteria:

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.

Exclusion Criteria:

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.
We found this trial at
12
sites
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Aurora, CO
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41 Burlington Mall Road
Burlington, Massachusetts 01805
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Burlington, MA
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Camperdown,
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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5841 South Maryland Avenue
Chicago, Illinois 60637
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Chicago, IL
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1411 North Beckley Avenue
Dallas, Texas 75203
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Dallas, TX
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3500 Gaston Ave
Dallas, Texas 75246
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Dallas, TX
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Detroit, Michigan 48202
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Detroit, MI
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Indianapolis, Indiana 46202
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Indianapolis, IN
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New York, NY
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
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Phoenix, AZ
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505 Parnassus Avenue
San Francisco, California 94143
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San Francisco, CA
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