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

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ClinicalTrials.gov Identifier: NCT01146808
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Transplantation Drug: Adefovir dipivoxil and hepatitis B vaccination Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADV plus hepatitis B vaccination
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.
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




Primary Outcome Measures :
  1. 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 ]
    Determined by hepatitis B serologies and viral load.


Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146808


Locations
United States, New York
Center for Liver Disease and Transplantation at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Gilead Sciences
Investigators
Principal Investigator: Robert S Brown, Jr, MD, MPH Center for Liver Disease and Transplantation at Columbia University Medical Center

Additional Information:
Publications:
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01146808     History of Changes
Other Study ID Numbers: AAAB8413
IN-US-103-0158 ( Other Identifier: Gilead )
First Posted: June 22, 2010    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Columbia University:
Vaccination
Immunocompromised Host
Antiviral Agents
Drug Resistance, Viral
Resource Allocation

Additional relevant MeSH terms:
Vaccines
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antibodies
Adefovir
Adefovir dipivoxil
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents