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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01146808
First received: June 16, 2010
Last updated: January 12, 2012
Last verified: January 2012

June 16, 2010
January 12, 2012
March 2006
July 2012   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Determined by hepatitis B serologies and viral load.
Same as current
Complete list of historical versions of study NCT01146808 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B
  • Liver Transplantation
Drug: Adefovir dipivoxil and hepatitis B vaccination
Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose
Other Name: Hepsera
Experimental: ADV plus hepatitis B vaccination
Intervention: Drug: Adefovir dipivoxil and hepatitis B vaccination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
July 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01146808
AAAB8413, IN-US-103-0158
No
Columbia University
Columbia University
Gilead Sciences
Principal Investigator: Robert S Brown, Jr, MD, MPH Center for Liver Disease and Transplantation at Columbia University Medical Center
Columbia University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP