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

Not Applicable

Not yet recruiting

• Conditions: Hepatitis B Virus (HBV); Lung Transplant Recipient
• Interventions: Drug: Entecavir; Biological: HBIG; Device: EVLP UV Light Treatment

• Registration Number: NCT07189377
• Lead Sponsor: University Health Network, Toronto

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

Detailed Description

The success of transplantation is significantly hindered by the lack of sufficient available donors. Many potential donor organs are not fully utilized in clinical transplantation because donors have chronic viral infections. Currently, donors with chronic hepatitis B virus (HBV) infection are typically excluded if the donor is NAT or Surface Ag positive. HBcAb+ve donors are routinely used, but NAT positive donors are typically not used. The Toronto lung transplant program commonly applies Ex Vivo Lung Perfusion (EVLP) to organs. This allows for treatment of organs prior to transplantation. The investigators have shown that UV light administered on the EVLP circuit can substantially decrease the amount of infectious virus. Such a strategy was previously employed with hepatitis C virus. The aim of the study is to show that transplantation of organs from HBV NAT+ve donors is safe with the use of UV light treatment on EVLP combined with post-transplant antivirals for the recipient (HBIG and entecavir). The investigators hypothesize that rates of HBV transmission to recipients will be prevented by the use of this approach and any HBV transmission that does occur will be readily treatable. This will be a small pilot study to determine the feasibility of this approach. If successful, the knowledge from this study can have an important impact on patients awaiting lung transplant by providing a strategy for use of HBV donors for organ transplantation.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UV Light + Short-course Entecavir/HBIG	Entecavir	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.
UV Light + Short-course Entecavir/HBIG	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.
UV Light + Short-course Entecavir/HBIG	EVLP UV Light Treatment	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.

Primary Outcome Measures

Name	Time	Method
Safety of transplantation using HBV positive donors reflected by negative HBV NAT at 6 months post-transplant	At 6 months post-transplant	Participant blood samples will be taken at days 3 and 7, then weekly for the first 4 weeks, then every two weeks until 12 weeks post-transplant, then at month 6 after transplantation. Blood samples will be tested for HBV DNA via Nucleic Acid Amplification.

Secondary Outcome Measures

Name	Time	Method
Incidence of any HBV donor to recipient transmission	From enrollment until 2 years post-transplant
Correlation between donor viremia level, and recipient infection	From enrollment until up to 2 years post-transplant
Interval of time from transplantation to viremia development	From enrollment until 2 years post-transplant
HBV suppression rates after treatment for infected patients	From time of infection until end of treatment or up to 2 years post-transplant
Adverse reactions to antiviral therapy	From enrollment until 2 years post-transplant
Incidence of acute liver dysfunction for infected patients	From enrollment until 2 years post-transplant
In-hospital mortality	From hospital admission until date of discharge or date of death from any cause, whichever comes first, assessed up to 2 years
1-year graft and patient survival	Measured 1 year post-transplant
Organ function at 1 year (FEV1)	Measured 1 year post-transplant
Development of anti-HBV antibodies (anti-HBs, anti-HBc)	From enrollment until 2 years post-transplant

Trial Locations

Locations (1)

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada