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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)

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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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Glecaprevir/Pibrentasvir
Experimental group
Description:
Glecaprevir/pibrentasvir (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Treatment:
Drug: glecaprevir/pibrentasvir

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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