Status:
WITHDRAWN
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
Lead Sponsor:
University of Pennsylvania
Conditions:
Lung Transplant
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 antibod...
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05404919
Start Date
September 6 2022
End Date
August 1 2024
Last Update
August 6 2024
Active Locations (1)
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1
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19146