Phase 4 Hepatitis B Trial, Recruiting NCT07189377 Sponsor: University Health Network, Toronto Condition: Hepatitis B
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Phase 4 Hepatitis B Trial, Recruiting

NCT07189377
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

(For organ donors:)

  • The donated lungs must be considered suitable for transplantation
  • The donor must have tested positive for Hepatitis B (either through a surface antigen test or a nucleic acid test)

(For recipients — the person receiving the lung):

  • You must already be on the waiting list and approved to receive a lung transplant
  • You must have tested negative for Hepatitis B (via a nucleic acid test)
  • You must be willing and able to sign a consent form agreeing to take part
  • You must have had at least 3 doses of the Hepatitis B vaccine in the past, or have a sufficient level of Hepatitis B antibodies in your blood (confirm with trial site)
  • You may still be eligible if you have other health conditions such as diabetes, autoimmune disease, or kidney problems, as long as you are otherwise healthy enough for a transplant

Who may not be able to join:

(For organ donors:)

  • The donor tested positive for HIV
  • The donor tested positive for HTLV 1 or 2 (a type of viral infection) (confirm with trial site)
  • The donor has any other medical issues that would normally prevent their organs from being used, such as a history of cancer or signs of organ damage

(For recipients — the person receiving the lung):

  • You have significant liver scarring or damage (more than stage 2 fibrosis) (confirm with trial site)
  • You are already taking part in another clinical trial that involves a treatment or intervention
  • You are listed to receive more than one organ at the same time (for example, a heart and lung together, or a lung and liver together)
  • You have a known allergy or medical reason you cannot take certain antiviral medications
  • You have already been infected with Hepatitis B, shown by a positive pre-transplant blood test
  • You are HIV positive
  • You have very low levels of a particular protein called IgA in your blood, which may increase the risk of a reaction to one of the medications used in the trial (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 416-340-4241

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
24 September 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Safety of transplantation using HBV positive donors reflected by negative HBV NAT at 6 months post-transplant

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov