NCT05849740招募中4 期
A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年5月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Total response rate to treatment (OR) Total response rate to treatment
研究概览
简要总结
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.
详细描述
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients.
Patients will receive Daratumumab and corticosteroid treatment in this trial.
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
- •Patients must meet all enrollment criteria before they can be enrolled:
- •Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance
排除标准
- •Patients with any of the following items cannot be enrolled in this study:
- •Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%).
- •Acquired von Willebrand disease
研究组 & 干预措施
Treatment arm
Experimental
Daratumumab and corticosteroid treatment
干预措施: Daratumumab and corticosteroid treatment (Drug)
结局指标
主要结局
Total response rate to treatment (OR) Total response rate to treatment
时间窗: During 8 weeks
The proportion of patients achieving OR including CR and PR
次要结局
- the proportion of patients with complete remission (CR)(During 8 weeks)
- the proportion of patients with partial remission rate (PR)(During 8 weeks)
- time to CR(During 8 weeks)
- The proportion of patients remaining in CR during 24 weeks(During 24 weeks)
- The proportion of patients relapse after reaching CR during 24 weeks(During 24 weeks)
- Safety outcome(From start of the treatment until the end of 24 weeks in the follow-up period)
研究者
研究点 (1)
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