drugset / Trial / NCT03249194

Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients

NCT03249194

Phase 0 Completed 25 enrolled Virginia Commonwealth University
NaSingle-groupOpen-labelTreatment

Summary

The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus (HCV) has changed the landscape of HCV therapy dramatically in the last several years with reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV positive patients including those who have received liver or kidney transplants. Since these new regimens do not include interferon and have already been studied in the post-liver and kidney transplant setting, they now offer a unique opportunity to expand the donor pool and improve the lives of those awaiting renal transplant. The address this gap in knowledge, the investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV medication to cure HCV soon after transplant would allow for safe transplantation of HCV positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable risks and improved survivals compared with historical cohorts.

Timeline

Start
2017-08-17
Primary completion
2020-03-15
Completion
2020-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Elbasvir Small molecule
Subject GRAZOPREVIR ANHYDROUS Small molecule
Subject Sofosbuvir Small molecule
Subject velpatasvir Other / unclassified