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

NCT07189377 | Recruiting Phase 4 DMC

• 1 other identifier: 24-6051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

HBV Disease; EVLP; lung transplant

Outcome Measures

Primary Outcomes (1)

• Safety of transplantation using HBV positive donors reflected by negative HBV NAT 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.

  At 6 months post-transplant

Secondary Outcomes (10)

• 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

Study Arms (1)

UV Light + Short-course Entecavir/HBIG

EXPERIMENTAL

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.

Drug: Entecavir; Biological: HBIG; Device: EVLP UV Light Treatment

Interventions

Entecavir DRUG

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.

UV Light + Short-course Entecavir/HBIG

HBIG BIOLOGICAL

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

UV Light + Short-course Entecavir/HBIG

EVLP UV Light Treatment DEVICE

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).

UV Light + Short-course Entecavir/HBIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donor lung suitable for transplantation
• HBV SAg positive and/or HBV NAT+ donor

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir; hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Atul Humar, MD, FRCPC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The antiviral used are both approved drugs (entecavir and HBIG) but being used for a new indication

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 23, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)