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

Primary Purpose

Hepatitis B, Liver Transplantation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adefovir dipivoxil and hepatitis B vaccination
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Vaccination, Immunocompromised Host, Antiviral Agents, Drug Resistance, Viral, Resource Allocation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Liver Disease and Transplantation at Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADV plus hepatitis B vaccination

Arm Description

Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose.

Outcomes

Primary Outcome Measures

Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL).

Secondary Outcome Measures

Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination
Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal

Full Information

First Posted
June 16, 2010
Last Updated
August 6, 2021
Sponsor
Columbia University
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01146808
Brief Title
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Liver Transplantation
Keywords
Vaccination, Immunocompromised Host, Antiviral Agents, Drug Resistance, Viral, Resource Allocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADV plus hepatitis B vaccination
Arm Type
Experimental
Arm Description
Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose.
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil and hepatitis B vaccination
Other Intervention Name(s)
Hepsera
Intervention Description
Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose
Primary Outcome Measure Information:
Title
Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver
Description
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL).
Time Frame
Standard of care visits post-transplant for 2 years
Secondary Outcome Measure Information:
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Brown, Jr, MD, MPH
Organizational Affiliation
Center for Liver Disease and Transplantation at Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Liver Disease and Transplantation at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7839446
Citation
Wachs ME, Amend WJ, Ascher NL, Bretan PN, Emond J, Lake JR, Melzer JS, Roberts JP, Tomlanovich SJ, Vincenti F, et al. The risk of transmission of hepatitis B from HBsAg(-), HBcAb(+), HBIgM(-) organ donors. Transplantation. 1995 Jan 27;59(2):230-4.
Results Reference
background
PubMed Identifier
14526400
Citation
Saab S, Chang AJ, Comulada S, Geevarghese SK, Anselmo RD, Durazo F, Han S, Farmer DG, Yersiz H, Goldstein LI, Ghobrial RM, Busuttil RW. Outcomes of hepatitis C- and hepatitis B core antibody-positive grafts in orthotopic liver transplantation. Liver Transpl. 2003 Oct;9(10):1053-61. doi: 10.1053/jlts.2003.50208.
Results Reference
background
Links:
URL
http://www.nlm.nih.gov/medlineplus/livertransplantation.html
Description
Liver Transplantation information from the NIH

Learn more about this trial

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

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