Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis B, Liver Transplantation

In brief

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.

Key facts

Study ID

NCT01146808

Run by

Columbia University

People needed

16

Starts

2006-03-01

Expected to finish

2012-09-01

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:
• received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,
• received adefovir treatment post transplantation, and
• who have not reached the 18 month post transplantation time period.

You may not qualify if…

• Recipients with hepatitis B surface antigen positivity prior to liver transplant.
• Grafts from hepatitis B surface antigen positive patients.
• Previous intolerance to ADV therapy
• Recipients with pre-transplant creatinine > 1.6 mg/dL
• Patients younger than 21 years of age
• Patients who are pregnant or breastfeeding

Where it is running

• Center for Liver Disease and Transplantation at Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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