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)

AbbVie

Status and phase

Completed

Phase 3

Conditions

HCV

Hepatitis C Virus

Chronic Hepatitis C

Treatments

Drug: glecaprevir/pibrentasvir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02692703

M13-596

2015-005616-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.