Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Biological, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Donor lung suitable for transplantation
• HBV SAg positive and/or HBV NAT+ donor
• Recipients eligible and listed for lung transplant
• HBV NAT negative
• Provides written informed consent
• Has received at least 3 prior doses of Hepatitis B vaccine or anti-HBs\>=10 IU/mL
• Patients with other co-morbid conditions (such as diabetes, autoimmune disease, renal dysfunction) will remain eligible provided they are otherwise medically suitable for transplantation. The exception to this will be patients with significant liver disease as outlined below.
Locations
Other Locations
Canada
University Health Network, Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Atul Humar, MD, FRCPC
atul.humar@uhn.ca
416-340-4241
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2027-08
Participants
Target number of participants: 20
Treatments
Experimental: UV Light + Short-course Entecavir/HBIG
Patients will receive lungs from HBV NAT+ donors, which will be treated with UV light therapy during ex-vivo perfusion. Patients will also receive Entecavir and HBIG prophylaxis in the immediate peri-operative period.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto