Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 190
- 试验地点
- 13
- 主要终点
- the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
研究概览
简要总结
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.
详细描述
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •treatment-naive patients with lymphoma
- •HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline
- •treated with chemotherapy and/or immunosuppressive therapy
- •life expectancy of more than 3 months
排除标准
- •younger than 18 years old
- •HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
- •pregnant or lactating women
研究组 & 干预措施
Entecavir prophylaxis
Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy.
干预措施: Entecavir prophylaxis (Drug)
Observation arm
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
干预措施: Observation arm (Drug)
结局指标
主要结局
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
时间窗: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
次要结局
- the incidence of hepatitis B virus maintained response, the incidence of hepatitis B virus sustained response, the incidence of hepatitis B virus relapse and hepatitis B virus relapse related hepatitis(from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy)
研究者
Jun Zhu
Peking University Cancer Hospital & Institute
Peking University