Risk of Hepatitis B Reactivation After Hematopoietic Stem Cell Transplantation in Donors and Recipients With Prior HBV Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- HBV reactivation (defined as detectable HBV DNA >20 IU/mL)
研究概览
简要总结
The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).
详细描述
Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
- •Documented anti-HBc (total)-positive.
排除标准
- •Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
- •Significant alcohol intake (>30 grams per day)
结局指标
主要结局
HBV reactivation (defined as detectable HBV DNA >20 IU/mL)
时间窗: 2 years
From date of hematopoietic stem cell transplantation (HSCT) to 2 years after HSCT.
次要结局
未报告次要终点