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Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
Sponsor: University Health Network, Toronto
Summary
The aim of the study is to show that transplantation of lungs from Hepatitis B-infected donors is safe when using EVLP with UV light inactivation plus antivirals
Official title: Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09-24
Completion Date
2027-08
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Entecavir
Recipients will receive 1mg administered orally, beginning pre-transplant as soon as the patient arrives to the hospital for surgery, and then 1mg post-operatively administered orally or via nasogastric tube once daily for 28 days.
HBIG
Recipients will receive 4500 IU intravenously pre-transplant and then at day 3 and 7 post-transplant (3 doses total).
EVLP UV Light Treatment
UV light therapy will be administered to the organ during EVLP prior to transplantation. For minimum 2 hours, maximum 6 hours (duration determined by time clinically required for EVLP based on standard clinical assessment of lung).
Locations (1)
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada