A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:1/12/2017
Start Date:April 2016
End Date:June 2017

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A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (MAGELLAN-2)

The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of
ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with
chronic Hepatitis C Virus infection.


Inclusion Criteria:

- Male or female, at least 18 years of age at time of screening.

- Screening laboratory result indicating HCV GT1 - 6 infection.

- Subject is a recipient of a cadaveric or living donor liver transplant which was a
consequence of HCV infection at least 3 months prior to screening Or Subject received
a cadaveric or living donor kidney at least 3 months before screening.

- Subjects must be documented as non-cirrhotic.

- Subject is currently taking a stable immunosuppression regimen based on tacrolimus,
sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine,
and/or cyclosporine.

Exclusion Criteria:

- Female subject who is pregnant, breastfeeding or is considering becoming pregnant
during the study or for approximately 30 days after the last dose of study drug.

- Clinical history of fibrosing cholestatic hepatitis post-transplant.

- Re-transplantation of the liver or kidney.

- Steroid resistant rejection of the transplanted liver or kidney, or a history of
rejection treated with high dose steroid within 3 months of screening.

- History of post-transplant complications related to hepatic or renal vasculature.
We found this trial at
11
sites
Philadelphia, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 149081, MD
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Philadelphia, PA
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Camperdown, 2050
Principal Investigator: Site Reference ID/Investigator# 149172, MD
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Camperdown,
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Chicago, IL
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Dallas, TX
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Detroit, MI
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Durham, North Carolina
Principal Investigator: Site Reference ID/Investigator# 149084, MD
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Durham, NC
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Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 149087, MD
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Indianapolis, IN
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Los Angeles, CA
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Murray, Utah 84107
Principal Investigator: Site Reference ID/Investigator# 149090, MD
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Murray, UT
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New York, NY
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San Francisco, California
Principal Investigator: Site Reference ID/Investigator# 149550, MD
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San Francisco, CA
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