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RECRUITING
NCT07189377
PHASE4

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-09-24

Completion Date

2027-08

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

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