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

Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial

This will try using lungs from hepatitis B–positive donors that are treated with UV light during ex vivo lung perfusion plus post-transplant antiviral medicines to see if they can be safely transplanted into HBV-negative lung transplant candidates.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT07189377 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are HBV NAT-negative adults listed for lung transplant who have prior hepatitis B vaccination or protective antibody levels and are otherwise medically suitable for transplantation.

Not a fit: Patients with significant chronic liver disease (> stage 2 fibrosis), those listed for combined organ transplants, or recipients unable or unwilling to receive HBIG and entecavir are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could expand the donor pool by safely allowing use of HBV-infected lungs while preventing HBV transmission to recipients.

How similar studies have performed: Similar EVLP plus UV light methods have been used to reduce hepatitis C infectivity previously, but applying this specific combination to prevent HBV transmission in lung transplantation is largely novel.

Eligibility criteria

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 this trial is running

Toronto, Ontario

• University Health Network, Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Atul Humar, MD, FRCPC

Conditions Hepatitis B Virus; Lung Transplant Recipient; HBV Disease; EVLP; lung transplant