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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Gilead Sciences
• Treatments: Adefovir; Adefovir dipivoxil; Antibodies; Vaccines

Criteria

Inclusion Criteria:

• Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:

1. received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,

2. received adefovir treatment post transplantation, and

3. who have not reached the 18 month post transplantation time period.

Exclusion Criteria:

• 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