Health TrialsbyHealthPanel

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

ConditionsHepatitis B Virus (HBV)Lung Transplant Recipient
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HBV SAg positive and/or HBV NAT+ donor

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • HBIG

    Biological/Vaccine

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

  • 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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: UV Light + Short-course Entecavir/HBIGExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
At 6 months post-transplant

Secondary outcomes

1

Incidence of any HBV donor to recipient transmission

Time frame
From enrollment until 2 years post-transplant
2

Correlation between donor viremia level, and recipient infection

Time frame
From enrollment until up to 2 years post-transplant
3

Interval of time from transplantation to viremia development

Time frame
From enrollment until 2 years post-transplant
4

HBV suppression rates after treatment for infected patients

Time frame
From time of infection until end of treatment or up to 2 years post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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