Status:
COMPLETED
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hepatitis B
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following tr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01146808
Start Date
March 1 2006
End Date
September 1 2012
Last Update
August 10 2021
Active Locations (1)
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1
Center for Liver Disease and Transplantation at Columbia University Medical Center
New York, New York, United States, 10032