Lung TransplantPhase 2INHIBITORNCT05404919
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
A Phase 2 study testing Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide in people with Lung Transplant and Hepatitis B, run by University of Pennsylvania at 1 site in United States.
Trial summary
The objective of this study is to determine the safety and efficacy of transplanting lungs from hepatitis B virus (HBV) nucleic acid test positive (NAT+) donors into HBV vaccinated HBV surface antibody positive (sAb+) lung transplant candidates, who will then be treated with Hepatitis B Immune Globulin (HBIG) and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplant, Hepatitis B
- What is being tested?
- Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Able to provide informed consent
- Willing and able to travel to the University of Pennsylvania for routine post-transplant study visits
- Pre-menopausal women must agree to use birth control in accordance with the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant
- Both men and women must agree to use at least one barrier method of birth control or remain abstinent following transplant due to risk of HBV transmission
- Appropriate HBV vaccine pre-transplant response, defined as HBV sAb ≥12.00 mIU/mL
Who cannot join
- Donor characteristics:
- Donation after circulatory death donor
- Hepatitis C Virus (HCV) NAT+
- PaO2/FiO2 <300 on FiO2 = 100% and PEEP=5
- Age >55 years
- Smoking history >20 pack years
Show all 21Show fewer
- Transplant candidate characteristics:
- Age >70 years
- Any chronic liver disease (excluding non-alcoholic fatty liver disease (NAFLD)) associated with persistently elevated liver enzymes
- Significant fibrosis (≥F2 on Fibroscan or Fib4 ≥1.67 (for patients unable to complete Fibroscan and without liver disease risk factors))
- Inadequate insurance coverage of entecavir, tenofovir disoproxil, or tenofovir alafenamide
- Retransplant candidate
- Current use of extracorporeal membrane oxygenation (ECMO) or mechanical ventilation as a bridge to lung transplantation
- HIV infection
- Chronic kidney disease with estimated glomerular filtrate rate less than 50 ml/min/1.73 m2
- Small bowel dysmotility or plan for prolonged medications and/or nutrition via tube route in the post-transplant period
- Significant human leukocyte antibody (HLA) sensitization (Calculated Panel Reactive Antibody (CPRA) ≥60%)
- Planned or high likelihood of anti-thymocyte globulin induction immunosuppression or rituximab treatment
- Known hypercoagulable states including positive antiphospholipid antibodies with prior venous or arterial thromboembolic events or Factor V Leiden or Prothrombin mutations with or without prior venous or arterial thromboembolic events
- History of hypersensitivity or anaphylactic reaction to immune globulin or similar products
- Receiving or anticipated to receive drugs with significant entecavir or tenofovir interactions including phenytoin/fosphenytoin, oxcarbazepine, phenobarbital, primidone, rifabutin, and rifampin
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19146
About this study
Official title: Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates
The objective of this study is to determine the safety and efficacy of transplanting lungs from hepatitis B virus (HBV) nucleic acid test positive (NAT+) donors into HBV vaccinated HBV surface antibody positive (sAb+) lung transplant candidates, who will then be treated with Hepatitis B Immune Globulin (HBIG) and entecavir, tenofovir disoproxil, or tenofovir alafenamide.
Read the detailed description
Despite advances in organ preservation and the use of increasingly sophisticated bridge-to-transplant therapies, there is significant waitlist mortality among lung transplant candidates. Between 2017-2019, 637 patients died while awaiting donor lungs and 403 became too sick for transplant. To increase the pool of available donors, many transplant programs in the United States now accept donors with active hepatitis C virus (HCV) infections. Transplant recipients are then treated with anti-viral therapy in the post-operative period.
Some kidney and lung transplant programs have extended this strategy to include donors with hepatitis B virus (HBV) viremia. Following transplant, recipients are treated with Hepatitis B Immune Globulin (HBIG) and life-long antiviral therapy. Published studies have shown decreased waitlist mortality among kidney recipients who receive HBV nucleic acid test positive (NAT+) organs without adverse impact on allograft or hepatic function. It is unknown, however, whether this can be a safe and effective strategy for lung transplant candidates.
The aim of this phase II clinical trial is to assess the safety and efficacy of accepting lungs from HBV NAT+ donors for HBV vaccinated lung transplant candidates. The study will enroll 10 subjects, who will be treated with HBIG and entecavir, tenofovir disoproxil, or tenofovir alafenamide following transplant. Outcomes will include rates of HBV viremia and time to undetectable viral level; rates of acute HBV-associated hepatitis and persistent HBsAg positivity at one year; and 1-year patient and graft survival.
- Conditions
- Lung Transplant, Hepatitis B
- Being tested
- Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamideDrug
Anti-hepatitis B medications
| Study group | Role | What they receive |
|---|---|---|
| Recipient of Hepatitis B NAT+ Donor | Other | All subjects will then be treated with Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide (choice of specific drug to be based on long-term cost, clinical response, and renal function) Receives: Drug: Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HBV viremia
HBV viremia rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Measured: 1 year
Time to undetectable HV DNA
Time to undetectable HBV DNA rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Measured: 1 year
Rate of acute HBV-associated hepatitis
Rates of acute HBV-associated hepatitis in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Measured: 1 year
Rate of persistent HBV surface antigen positivity
Rates of persistent HBV surface antigen (HBsAg) positivity at one year in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Measured: 1 year
Secondary outcomes (2)
One year patient survival
One year patient survival among lung transplant patients who receive an organ from a HBV NAT+ donor.
Measured: 1 year
One year graft survival
One year graft survival among lung transplant patients who receive an organ from a HBV NAT+ donor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start6 Sep 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024 (estimated)
Why it stopped: Insufficient enrollment; departure of primary investigator from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew M Courtwright, University of Pennsylvania
- Investigators
- Andrew M Courtwright, MD, PhD, Principal investigator, Hospital of University of Pennsyvlania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404919
- Sponsor's protocol ID
- 851257
- Acronym
- INHIBITOR
- Status last verified
- Aug 2024
- First submitted
- 7 May 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates
- ClinicalTrials.gov ID
- NCT05404919
- Acronym / sponsor ID
- INHIBITOR / 851257
- Conditions
- Lung Transplant, Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment; departure of primary investigator from institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Jun 2022 (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 objective of this study is to determine the safety and efficacy of transplanting lungs from hepatitis B virus (HBV) nucleic acid test positive (NAT+) donors into HBV vaccinated HBV surface antibody positive (sAb+) lung transplant candidates, who will then be treated with Hepatitis B Immune Globulin (HBIG) and entecavir, tenofovir disoproxil, or tenofovir alafenamide.
Detailed description
Despite advances in organ preservation and the use of increasingly sophisticated bridge-to-transplant therapies, there is significant waitlist mortality among lung transplant candidates. Between 2017-2019, 637 patients died while awaiting donor lungs and 403 became too sick for transplant. To increase the pool of available donors, many transplant programs in the United States now accept donors with active hepatitis C virus (HCV) infections. Transplant recipients are then treated with anti-viral therapy in the post-operative period.
Some kidney and lung transplant programs have extended this strategy to include donors with hepatitis B virus (HBV) viremia. Following transplant, recipients are treated with Hepatitis B Immune Globulin (HBIG) and life-long antiviral therapy. Published studies have shown decreased waitlist mortality among kidney recipients who receive HBV nucleic acid test positive (NAT+) organs without adverse impact on allograft or hepatic function. It is unknown, however, whether this can be a safe and effective strategy for lung transplant candidates.
The aim of this phase II clinical trial is to assess the safety and efficacy of accepting lungs from HBV NAT+ donors for HBV vaccinated lung transplant candidates. The study will enroll 10 subjects, who will be treated with HBIG and entecavir, tenofovir disoproxil, or tenofovir alafenamide following transplant. Outcomes will include rates of HBV viremia and time to undetectable viral level; rates of acute HBV-associated hepatitis and persistent HBsAg positivity at one year; and 1-year patient and graft survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipient of Hepatitis B NAT+ Donor | Other | Drug: Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamideAll subjects will then be treated with Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide (choice of specific drug to be based on long-term cost, clinical response, and renal function) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-70 years
- Able to provide informed consent
- Willing and able to travel to the University of Pennsylvania for routine post-transplant study visits
- Pre-menopausal women must agree to use birth control in accordance with the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant
- Both men and women must agree to use at least one barrier method of birth control or remain abstinent following transplant due to risk of HBV transmission
Key exclusion criteria (21 listed)
- Donor characteristics:
- Transplant candidate characteristics:
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 |
|---|---|---|
| Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamideAnti-hepatitis B medications | Drug | Recipient of Hepatitis B NAT+ Donor |
Primary outcome
Rate of HBV viremia
Time frame: 1 year
HBV viremia rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Time to undetectable HV DNA
Time frame: 1 year
Time to undetectable HBV DNA rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Rate of acute HBV-associated hepatitis
Time frame: 1 year
Rates of acute HBV-associated hepatitis in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
Rate of persistent HBV surface antigen positivity
Time frame: 1 year
Rates of persistent HBV surface antigen (HBsAg) positivity at one year in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.
2 secondary outcomes
One year patient survival
Time frame: 1 year
One year graft survival
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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. This study is not recruiting at the moment.
Andrew M Courtwright, MD, PhD principal investigator
Hospital of University of Pennsyvlania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide in people with Lung Transplant and Hepatitis B, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 6 Aug 2024. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HBV viremia (time frame: 1 year). The study lists 4 primary outcomes in all. 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 6 Aug 2024.