Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- the incidence of hepatitis B virus delayed reactivation
研究概览
简要总结
This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.
详细描述
All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment-naive patients with lymphoma
- •patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive
排除标准
- •HBsAg and HBcAb negative
结局指标
主要结局
the incidence of hepatitis B virus delayed reactivation
时间窗: within one year after withdrawal of prophylactic antiviral therapy
hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy
次要结局
- Number of patients that achieve a tumor response(within one year after withdrawal of prophylactic antiviral therapy)
- overall survival rate(within one year after withdrawal of prophylactic antiviral therapy)
- the incidence of hepatitis B virus related hepatitis flare(within one year after withdrawal of prophylactic antiviral therapy)
研究者
Jun Zhu
Chairman of lymphoma department
Peking University