A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal … (NCT02692703) | Clinical Trial Compass
CompletedPhase 3
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)
100 participantsStarted 2016-04-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Timeframe: 12 weeks after the last dose of study drug (up to 24 weeks)