Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates

Withdrawn before enrolling · Phase 2

Conditions studied: Lung Transplant, Hepatitis B

In brief

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.

Key facts

Study ID

NCT05404919

Run by

University of Pennsylvania

People needed

0

Starts

2022-09-06

Expected to finish

2024-08-01

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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