The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- success rate of ITI success rate of ITI success rate of ITI success rate of ITI
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 with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
详细描述
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The patient has contraindications to drug ingredients or hamster protein allergy;
- •Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
- •Failed systemic ITI treatment in history;
- •Poor patients compliance;
- •The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
研究组 & 干预措施
SCT800 combined with Daratumumab
ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months.
干预措施: SCT800 and Daratumumab (Drug)
SCT800 alone
ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.
干预措施: SCT800 (Drug)
结局指标
主要结局
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
时间窗: 12 months
Inhibitor titre \<0.6 BU⁄mL
Success rate and partial success rate of ITI after 3-month treatment
时间窗: 3 months
Inhibitor titre \<0.6 BU⁄mL
次要结局
- ITI success time(12 months)