Actively Recruiting
Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
Led by University Health Network, Toronto · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of transplanting lungs from donors infected with Hepatitis B virus (HBV) using a combination of ex vivo lung perfusion (EVLP) with ultraviolet (UV) light inactivation and antiviral treatments. The study focuses on organs from donors who are HBV NAT positive, a group typically not used due to concerns about virus transmission. The goal is to determine if this approach can prevent HBV transmission to recipients and offer a new option for patients awaiting lung transplants. Participants will receive lungs from HBV NAT positive donors, with the donor lungs treated using UV light therapy during EVLP before transplantation. Recipients will also be given antiviral medications, including Entecavir orally for 28 days starting before surgery, and Hepatitis B Immune Globulin (HBIG) intravenously in three doses around the time of transplant. The UV light treatment duration varies between 2 to 6 hours depending on clinical assessment during EVLP. During the study, participants will be monitored for safety by testing for HBV presence six months after transplant and tracked for up to two years for HBV transmission, viral activity, liver function, and survival outcomes. Researchers will assess lung function, immune response to HBV, and any adverse reactions to antiviral therapy. The total study period includes initial transplant, antiviral treatment, and long-term follow-up to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief Title
Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donor lung suitable for transplantation
- Donor is Hepatitis B surface antigen positive and/or Hepatitis B NAT positive
- Recipient is eligible and listed for lung transplant
- Recipient is Hepatitis B NAT negative
- Recipient provides written informed consent
- Recipient has received at least 3 prior doses of Hepatitis B vaccine or has anti-HBs ≥10 IU/mL
- Patients with other co-morbid conditions are eligible if otherwise suitable for transplantation except those with significant liver disease
You will not qualify if you...
- Donor is HIV positive
- Donor is HTLV 1/2 positive
- Donor has medical issues normally excluding donation (e.g., history of cancer, organ dysfunction)
- Recipient has chronic liver disease with greater than stage 2 fibrosis
- Recipient is participating in another interventional clinical trial
- Recipient is listed for combined transplant (e.g., heart-lung, lung-liver)
- Recipient has known allergy or contraindication to antiviral medications
- Recipient is Hepatitis B surface antigen or core antibody positive pre-transplant
- Recipient is HIV positive
- Recipient has low serum IgA pre-transplant (risk for sensitivity to HBIG)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 6 hours
Participants receive lungs from HBV NAT positive donors treated with UV light therapy during ex-vivo lung perfusion prior to transplantation.
1 visit (in-person, during transplantation)
Duration - 28 days
Participants receive antiviral prophylaxis including entecavir starting pre-transplant and continuing daily for 28 days, and HBIG intravenously pre-transplant and on days 3 and 7 post-transplant.
At least 4 visits (pre-transplant, day 0, day 3, and day 7 post-transplant)
Duration - Up to 2 years
Participants are monitored for safety, HBV transmission, graft function, and survival for up to 2 years post-transplant.
Regular follow-up visits as per transplantation care protocol
Trial Site Locations
Total: 1 location
1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
A
Atul Humar, MD, FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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