Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 34
- 主要终点
- Primary objective
研究概览
简要总结
CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.
详细描述
CREHA project is a multicenter, randomized, controlled efficacity and safety study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •men or women
- •women post-menpausal or with ongoing contraception
- •18 years old or more
- •diagnosis of acquired hemophilia
- •patient must be insured
- •patient has provided written informed consent prior to enrolment
- •patient compliant
排除标准
- •constitutional hemophilia
- •chemotherapy
- •ongoing treatment with prednisone > 20mg further more 1 month
- •ongoing treatment with prednisone >0.7 mg/d further more 10 days
- •thrombocytopenia
- •leukopenia
- •chronic disease
研究组 & 干预措施
Bras B
Steroid 1mg/kg/d and Rituximab 375 mg/m2 every week during four weeks
干预措施: Steroid + rituximab (Drug)
Bras A
Steroid 1mg/kg/d and Cyclophosphamide 2mg/kg/d
干预措施: Steroid + cyclophosphamide (Drug)
结局指标
主要结局
Primary objective
时间窗: During 18 months
Demonstrate the inferiority of steroid combined with rituximab as compared to the recommended immunosuppressive approach (steroid combined with cysclophosphamide for 21 to 42 days) as the first-line immunosuppressive therapy for FVIII inhibitor eradication in acquired haemophilia
Primary efficacy outcome
时间窗: During 18 months
The primary efficacy outcome is the proportion of patients achieving complete remission defined as titer FVII inhibitor lower than 0.4 Bethesda unit and factor VIII level \> 50%
Primary safety outcomes
时间窗: During 18 months
The primary safety outcomes will be the occurrence of major bleeding and infection related immunosuppressive treatment adverse events.
次要结局
- Secondary objective(6 months, 12 months and 18 months)
- Other key safety outcome(During 18 months)