Phase 3
Completed N=100
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)
Chronic Hepatitis C · HCV · Hepatitis C
Source: ClinicalTrials.gov NCT02692703 ↗
Enrolled (actual)
100
Serious AEs
8.0%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 98 percentage of participants
◆ Published Evidence
Highly cited
181citations · ~23 / year
Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection.
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.
Linked Publications
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Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
98 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02692703) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.