Transplanting Hepatitis C Positive Thoracic Organs
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | March 1, 2017 |
| End Date: | December 2021 |
| Contact: | Ann Woolley, MD |
| Email: | awoolley@bwh.harvard.edu |
| Phone: | 617-732-5500 |
Transplanting Thoracic 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
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).
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).
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.
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.
Inclusion Criteria:
- 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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-8418
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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