Overview

This trial is active, not recruiting.

Conditions hepatitis b, liver transplantation
Treatment adefovir dipivoxil and hepatitis b vaccination
Sponsor Columbia University
Collaborator Gilead Sciences
Start date March 2006
End date July 2012
Trial size 16 participants
Trial identifier NCT01146808, AAAB8413, IN-US-103-0158

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adefovir dipivoxil and hepatitis b vaccination Hepsera
Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Primary Outcomes

Measure
Development of de novo hepatitis B infection after transplant with a core antibody positive liver
time frame: Standard of care visits post-transplant for 2 years

Secondary Outcomes

Measure
Proportion of patients with a sustained hepatitis B surface antibody titer > 500 IU/mL prior to and after vaccination
time frame: 12-18 months post transplant
Proportion of patients who develop de novo hepatitis B infection post ADV withdrawal, which will be assessed at 6 months post withdrawal
time frame: Six months after hepatitis B vaccination (2 years post transplant)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Robert S Brown, Jr, MD, MPH
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 transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb >500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Columbia University.