Hepatitis C Positive Donor Into Hepatitis C Negative Recipients
Status:
Withdrawn
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
Despite many efforts to increase the size of the donor pool, there is a large and growing
disparity between the number of donor kidneys and livers available for transplantation and
the number of patients on the transplant waiting list. New donor pools are needed to satisfy
the lack of available donor organs, along with expanded criteria for the existing donor
pools.
A new standard of care now exists at most local and regional transplant centers. This new
standard of care is based on the use of multiple direct-acting antiviral agents (DAAs) for
treatment of hepatitis C virus (HCV) that have been approved by the Food and Drug
Administration (FDA) for the treatment of hepatitis C and are associated with high HCV cure
rates and minimal side effect profiles. The efficacy and tolerability of these medications
has allowed the expansion of the available donor pool by making HCV antibody positive non
viremic organs and HCV-viremic organs (when HCV is detectable in the blood) available to
HCV-naive recipients on the organ transplantation waiting list. Expansion of this donor pool
may decrease time on the waiting list and improve quality of life and survival while waiting
for organ transplantation.
Study Aim:
We propose a clinical protocol to utilize solid organs from exposed and/or HCV-viremic organ
donors for transplantation into HCV negative recipients.
The primary purpose of the clinical protocol is to:
Collect prospective standard of care laboratory data on the results of these interventions
Phase:
Early Phase 1
Details
Lead Sponsor:
University of Maryland University of Maryland, College Park
Treatments:
Antiviral Agents Ledipasvir Ledipasvir, sofosbuvir drug combination Ribavirin Sofosbuvir