At a glance
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Prevention of de Novo Hepatitis B Infection With Adefovir Dipivoxil (ADV) and Hepatitis B Vaccination in HBsAg Seronegative Recipients of Liver Grafts From Hepatitis B Core Antibody Positive (HBcAb+) Donors
In Brief
A Phase 2 clinical trial evaluating Adefovir dipivoxil and hepatitis B vaccination for Hepatitis B and Liver Transplantation. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.
Study Details
Timeline
Interventions
Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose