NCT05453435进行中（未招募）2 期
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) (REHEB)：a Single Arm, Open Label, Multi-center Phase II Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Cumulative HBV reactivation rate
研究概览
简要总结
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).
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
- •Histopathologically confirmed CD20 positive B-cell lymphoma;
- •Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;
- •Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;
- •Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;
- •ECOG PS: 0~2;
- •Estimated survival time >3 months.
排除标准
- •Positive HBsAg or HBV-DNA higher than the detection limit at baseline;
- •Previous chemotherapy or radiotherapy for lymphoma;
- •Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;
- •Pregnant or lactating women;
- •History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.
研究组 & 干预措施
Entecavir prophylaxis
Experimental
0.5mg qd
干预措施: Entecavir (Drug)
结局指标
主要结局
Cumulative HBV reactivation rate
时间窗: 12 months
Cumulative incidence of hepatitis B virus reactivation
次要结局
- Incidence of HBV-related liver failure(12 months)
- Incidence of HBV-related chemotherapy disruption(12 months)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University
研究点 (1)
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