Recruiting

Lung Transplantation with Antivirals

Sponsor:

University Health Network, Toronto

Code:

NCT07189377

Conditions

Hepatitis B Virus (HBV)

Lung Transplant Recipient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Entecavir

HBIG

EVLP UV Light Treatment

Study Details

Brief 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

Conditions

Hepatitis B Virus (HBV)

Lung Transplant Recipient

Study ID

NCT07189377

Start date

Sep 24, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: UV Light + Short-course Entecavir/HBIG

Patients will receive lungs from HBV NAT+ donors, which will be treated with UV light therapy during ex-vivo perfusion. Patients will also receive Entecavir and HBIG prophylaxis in the immediate peri-operative period.

Interventions

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.

HBIG

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

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).

Primary outcome measure

  • Safety of transplantation using HBV positive donors reflected by negative HBV NAT at 6 months post-transplant [ Time Frame: At 6 months post-transplant ]

Central Contacts and Locations

Central contacts

Atul Humar, MD, FRCPC

416-340-4241atul.humar@uhn.ca

Locations

University Health Network, Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Ilona Bahinskaya, MSc, CCRP

416-340-4800Ilona.Bahinskaya@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 17, 2025

Last verified

Aug, 2025

Keywords

  • HBV Disease
  • EVLP
  • lung transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-11-17.