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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Hepatitis B Virus (HBV)Lung Transplant Recipient
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).

Trial Locations (1)

M5G 2C4

University Health Network, Toronto General Hospital, Toronto

All Listed Sponsors
lead

University Health Network, Toronto

OTHER