Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
University Health Network, Toronto
20 participants
Sep 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria10
- HIV positive
- HTLV 1/2 positive;
- Any medical issues in the donor that would normally clinically exclude the donor (e.g. history of cancer, evidence of organ dysfunction, etc).
- Chronic liver disease with \> stage 2 fibrosis
- Participating in another interventional clinical trial
- Recipient listed for combined transplant (e.g., heart-lung, lung-liver)
- Known allergy or contraindication to any of the antiviral medications
- Hepatitis B surface antigen (HBsAg) or Hepatitis B core Ab positive pre-transplant (indicates already HBV infected).
- HIV positive
- Patients with a low level of serum IgA pre-transplant (this may be a risk factor for sensitivity reaction to HBIG).
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Interventions
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.
Recipients will receive 4500 IU intravenously pre-transplant and then at day 3 and 7 post-transplant (3 doses total).
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07189377