Transplanting Hepatitis C Positive Thoracic Organs

  • STATUS
    Recruiting
  • End date
    Dec 22, 2021
  • participants needed
    100
  • sponsor
    Brigham and Women's Hospital
Updated on 22 January 2021
sofosbuvir
velpatasvir

Summary

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart or lung 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).

Description

This is an open label pilot study transplanting thoracic organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart and lung transplant participants will be stratified into two different study arms depending on whether the donor of the thoracic 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, or at the earliest time point post-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.

Details
Condition Hepatitis C, Hepatitis C virus, Awaiting Organ Transplant
Treatment Monitoring, sofosbuvir/velpatasvir
Clinical Study IdentifierNCT03086044
SponsorBrigham and Women's Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hepatitis C virus or Awaiting Organ Transplant or Hepatitis C?
Do you have any of these conditions: Hepatitis C virus or Hepatitis C or Awaiting Organ Transplant?
Men and women who are age 18 years
Active on either the cardiac or lung transplant waiting list
Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria

HIV antibody or HIV NAT positive
Hepatitis B surface antigen or Hepatitis B NAT or viral load positive
Evidence of cirrhosis or clinically significant liver disease
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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