Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors

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

Eligibility

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).

Conditions3

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