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RECRUITINGPhase 4INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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

Who May Be Eligible (Plain English)

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 Who May Qualify: - Recipients eligible and listed for lung transplant - HBV NAT negative - Provides written willing to sign a consent form - 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 conditions (where your immune system attacks your own body), 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

Entecavir

Recipients will receive 1mg administered orally, beginning pre-transplant as soon as the patient arrives to the hospital for surgery, and then 1mg post-operatively administered orally or via nasogastric tube once daily for 28 days.

BIOLOGICAL

HBIG

Recipients will receive 4500 IU intravenously pre-transplant and then at day 3 and 7 post-transplant (3 doses total).

DEVICE

EVLP UV Light Treatment

UV light therapy will be administered to the organ during EVLP prior to transplantation. For minimum 2 hours, maximum 6 hours (duration determined by time clinically required for EVLP based on standard clinical assessment of lung).

Locations (1)

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