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Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients
This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).
This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Brigham and Women's Hospital
Boston, Massachusetts, United States
Start Date
March 1, 2017
Primary Completion Date
December 1, 2023
Completion Date
December 1, 2023
Last Updated
October 12, 2022
148
ESTIMATED participants
Sofosbuvir/velpatasvir
DRUG
Monitoring
OTHER
Lead Sponsor
Brigham and Women's Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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