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NCT Number: NCT01146808

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Liver Transplantation Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Center for Liver Disease and Transplantation at Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adefovir dipivoxil and hepatitis B vaccination

Drug

Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Other names: Hepsera

Primary outcomes

  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 positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL).

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Jun 22, 2010
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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