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Could UV light make hepatitis b donor lungs safe for transplant?

NCT ID NCT07189377

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether lungs from donors with hepatitis B can be safely given to people who do not have hepatitis B. The donated lungs are treated with UV light during a special preservation process, and recipients receive antiviral drugs and antibodies to prevent infection. Twenty lung transplant candidates will be enrolled to see if this approach prevents transmission of the virus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Entecavir (antiviral drug), HBIG (antibodies), and UV light treatment of the donor lung
What this could lead to
If successful, this could safely expand the pool of donor lungs for transplant, reducing wait times for people needing a lung transplant.
What could go wrong
This is a small early safety trial with only 20 participants, so results may not apply broadly. There is a risk of hepatitis B transmission despite treatment, and side effects from the antiviral drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Donor Inclusion Criteria * Donor lung suitable for transplantation * HBV SAg positive and/or HBV NAT+ donor Donor Exclusion Criteria * 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). Recipient inclusion Criteria: * 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. Recipient exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B virus (HBV) Lung transplant recipient

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Health Network, Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

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