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Eligibility
for people ages 18 years to 99 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

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)

Keywords

Chronic Hepatitis C HCV Hepatitis C Virus HCV Treatment Experienced Hepatitis C HCV Genotype 3 Without cirrhosis Non-cirrhotic HCV Genotype 2 Renal Transplant HCV Treatment Naive Post transplant HCV Genotype 6 Liver Transplant HCV Genotype 5 HCV Genotype 4 Kidney Transplant HCV Genotype 1

Eligibility

You can join if…

Open to people ages 18 years to 99 years

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Site Reference ID/Investigator# 149078
    Los Angeles, California, 90048, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02692703
Phase
Phase 3
Study Type
Interventional
Last Updated
January 2017