Safety Study of Lung Transplantation Using Hepatitis B Positive Donor Organs Treated with UV Light and Short-Course Antiviral Therapy

What this Trial Is About

This research aims to evaluate the safety of transplanting lungs from donors infected with Hepatitis B virus HBV using a combination of ex vivo lung perfusion EVLP with ultraviolet UV light inactivation and antiviral treatments. The study focuses on organs from donors who are HBV NAT positive, a group typically not used due to concerns about virus transmission. The goal is to determine if this approach can prevent HBV transmission to recipients and offer a new option for patients awaiting lung transplants. Participants will receive lungs from HBV NAT positive donors, with the donor lungs treated using UV light therapy during EVLP before transplantation. Recipients will also be given antiviral medications, including Entecavir orally for 28 days starting before surgery, and Hepatitis B Immune Globulin HBIG intravenously in three doses around the time of transplant. The UV light treatment duration varies between 2 to 6 hours depending on clinical assessment during EVLP. During the study, participants will be monitored for safety by testing for HBV presence six months after transplant and tracked for up to two years for HBV transmission, viral activity, liver function, and survival outcomes. Researchers will assess lung function, immune response to HBV, and any adverse reactions to antiviral therapy. The total study period includes initial transplant, antiviral treatment, and long-term follow-up to gather comprehensive safety and effectiveness data.

Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors