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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Adefovir dipivoxil and hepatitis B vaccination (Drug)
结局指标
主要结局
Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver
时间窗: 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).
次要结局
- Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination(12-18 months post transplant)
- Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal(Six months after hepatitis B vaccination (2 years post transplant))