Status:
RECRUITING
Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatitis B Virus (HBV)
Lung Transplant Recipient
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Detailed Description
The success of transplantation is significantly hindered by the lack of sufficient available donors. Many potential donor organs are not fully utilized in clinical transplantation because donors have ...
Eligibility Criteria
Inclusion
- Donor Inclusion Criteria
- Donor lung suitable for transplantation
- HBV SAg positive and/or HBV NAT+ donor
- Donor Exclusion Criteria
- 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).
- Recipient inclusion Criteria:
- 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.
- Recipient exclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
September 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07189377
Start Date
September 24 2025
End Date
August 1 2027
Last Update
November 17 2025
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4