UV-treated, antiviral-protected lungs from Hepatitis B–positive donors for transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial treats HBV NAT-positive donor lungs with ultraviolet (UV) light during ex vivo lung perfusion (EVLP) and transplants them into HBV-negative recipients who receive hepatitis B immune globulin (HBIG) and entecavir after surgery. Recipients must be listed for lung transplant, be HBV NAT-negative, and have prior hepatitis B vaccination or protective antibody levels. The primary outcome is safety and prevention of donor-derived HBV transmission, monitored by serial viral testing. The intervention is performed at the University Health Network using established EVLP protocols combined with antiviral prophylaxis.

Why it matters

Who can join: the full rules

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).

Where it's running

• University Health Network, Toronto General Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Atul Humar, MD, FRCPC
• Email: atul.humar@uhn.ca
• Phone: 416-340-4241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.