Testing lungs from hepatitis B donors in lung transplant patients
Tests whether lungs from hepatitis B-infected donors can be used safely in adults.
Plain-language title generated from the registry record
Registry title: Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 4
Where in Canada
- University Health Network, Toronto General HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT07189377
- Record updated
- 17 November 2025
- Original description
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 antiviralsRead full original descriptionShow less
Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
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
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).