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

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2010

Last Updated Date

January 12, 2012

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01146808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis B
Liver Transplantation

Intervention ^ICMJE

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

Study Arm (s)

Experimental: ADV plus hepatitis B vaccination

Intervention: Drug: Adefovir dipivoxil and hepatitis B vaccination

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01146808

Other Study ID Numbers ^ICMJE

AAAB8413, IN-US-103-0158

Has Data Monitoring Committee

Responsible Party

Columbia University

Study Sponsor ^ICMJE

Columbia University

Collaborators ^ICMJE

Gilead Sciences

Investigators ^ICMJE

Principal Investigator:

Robert S Brown, Jr, MD, MPH

Center for Liver Disease and Transplantation at Columbia University Medical Center

Information Provided By

Columbia University

Verification Date

January 2012

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

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