drugset / Trial / NCT05404919

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

NCT05404919

Phase 2 Withdrawn University of Pennsylvania
NaSingle-groupOpen-labelTreatment

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 entecavir, tenofovir disoproxil, or tenofovir alafenamide.

Timeline

Start
2022-09-06
Primary completion
2024-08-01
Completion
2024-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Entecavir Small molecule
Subject Tenofovir disoproxil fumarate Small molecule
Subject tenofovir alafenamide Small molecule
Background hepatitis B immune globulin Protein / enzyme biologic