Expired Study
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New York, New York 10032


Purpose:

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 summary:

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.


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


NCT ID:

NCT01146808


Primary Contact:

Principal Investigator
Robert S Brown, Jr, MD, MPH
Center for Liver Disease and Transplantation at Columbia University Medical Center


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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