Overview

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:
Completed
Trial end date:
2017-06-29
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Criteria
Inclusion Criteria:

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

- Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (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.