Hepatitis B Virus (HBV)Phase 4CLEAR-HBVNCT07189377
Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
A Phase 4 study testing Entecavir, HBIG and EVLP UV Light Treatment in people with Hepatitis B Virus (HBV) and Lung Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Virus (HBV), Lung Transplant Recipient
- What is being tested?
- Entecavir, HBIG and EVLP UV Light Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2025to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
Ilona Bahinskaya, MSc, CCRP, 416-340-4800 ext. 4328, Ilona.Bahinskaya@uhn.ca
About this study
Official title: Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety 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
Read the 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 utilized by typically providing nucleoside analogues such as entecavir or lamivudine plus/minus several doses of HBIG. The entecavir or lamivudine are typically given either life-long in liver transplants or for 1 year in non-liver transplants. Donors with chronic HBV infection are Core Antibody positive (HBcAb +ve). These donors carry chronic virus but may be NAT positive or NAT negative. 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 transplantation by providing a novel strategy for the use of HBV-positive organ donors, simplified through a shorter course of approved antivirals.
- Conditions
- Hepatitis B Virus (HBV), Lung Transplant Recipient
- Being tested
- Entecavir, HBIG, EVLP UV Light Treatment
- Keywords
- HBV Disease, EVLP, lung transplant
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
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.
HBIGBiological
Recipients will receive 4500 IU intravenously pre-transplant and then at day 3 and 7 post-transplant (3 doses total).
EVLP UV Light TreatmentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Entecavir; Biological: HBIG; Device: EVLP UV Light Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months post-transplant
Secondary outcomes (10)
Incidence of any HBV donor to recipient transmission
Measured: From enrollment until 2 years post-transplant
Correlation between donor viremia level, and recipient infection
Measured: From enrollment until up to 2 years post-transplant
Interval of time from transplantation to viremia development
Measured: From enrollment until 2 years post-transplant
HBV suppression rates after treatment for infected patients
Measured: From time of infection until end of treatment or up to 2 years post-transplant
Adverse reactions to antiviral therapy
Measured: From enrollment until 2 years post-transplant
Incidence of acute liver dysfunction for infected patients
Measured: From enrollment until 2 years post-transplant
In-hospital mortality
Measured: 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: Measured 1 year post-transplant
Organ function at 1 year (FEV1)
Measured: Measured 1 year post-transplant
Development of anti-HBV antibodies (anti-HBs, anti-HBc)
Measured: From enrollment until 2 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start24 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus (HBV)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The antiviral used are both approved drugs (entecavir and HBIG) but being used for a new indication
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189377
- Sponsor's protocol ID
- 24-6051
- Acronym
- CLEAR-HBV
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial
- ClinicalTrials.gov ID
- NCT07189377
- Acronym / sponsor ID
- CLEAR-HBV / 24-6051
- Conditions
- Hepatitis B Virus (HBV), Lung Transplant Recipient
- Keywords
- HBV Disease, EVLP, lung transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 utilized by typically providing nucleoside analogues such as entecavir or lamivudine plus/minus several doses of HBIG. The entecavir or lamivudine are typically given either life-long in liver transplants or for 1 year in non-liver transplants. Donors with chronic HBV infection are Core Antibody positive (HBcAb +ve). These donors carry chronic virus but may be NAT positive or NAT negative. 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 transplantation by providing a novel strategy for the use of HBV-positive organ donors, simplified through a shorter course of approved antivirals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The antiviral used are both approved drugs (entecavir and HBIG) but being used for a new indication
| Arm | Type | Receives |
|---|---|---|
| UV Light + Short-course Entecavir/HBIG | Experimental | Drug: Entecavir, Biological: HBIG, Device: EVLP UV Light TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntecavirRecipients 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. | Drug | UV Light + Short-course Entecavir/HBIG |
| HBIGRecipients will receive 4500 IU intravenously pre-transplant and then at day 3 and 7 post-transplant (3 doses total). | Biological | UV Light + Short-course Entecavir/HBIG |
| EVLP UV Light TreatmentUV 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). | Device | UV Light + Short-course Entecavir/HBIG |
Primary outcome
Safety of transplantation using HBV positive donors reflected by negative HBV NAT at 6 months post-transplant
Time frame: 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.
10 secondary outcomes
Incidence of any HBV donor to recipient transmission
Time frame: From enrollment until 2 years post-transplant
Correlation between donor viremia level, and recipient infection
Time frame: From enrollment until up to 2 years post-transplant
Interval of time from transplantation to viremia development
Time frame: From enrollment until 2 years post-transplant
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
Adverse reactions to antiviral therapy
Time frame: From enrollment until 2 years post-transplant
Incidence of acute liver dysfunction for infected patients
Time frame: From enrollment until 2 years post-transplant
In-hospital mortality
Time frame: 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
Time frame: Measured 1 year post-transplant
Organ function at 1 year (FEV1)
Time frame: Measured 1 year post-transplant
Development of anti-HBV antibodies (anti-HBs, anti-HBc)
Time frame: From enrollment until 2 years post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir, HBIG and EVLP UV Light Treatment in people with Hepatitis B Virus (HBV) and Lung Transplant Recipient, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atul Humar, MD, FRCPC (416-340-4241, atul.humar@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of transplantation using HBV positive donors reflected by negative HBV NAT at 6 months post-transplant (time frame: At 6 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.