招募患者：未接受过治疗的儿童血友病A患者中应用turoctocog alfa预防和治疗出血的安全性和有效性临床试验

2015-09-09 MedSci MedSci原创

1.  试验药物简介 Turoctocog alpha（商品名NovoEight）是第三代重组凝血因子VIII，用于A型血友病患者出血事件的预防和治疗。2013年10月FDA批准NovoEight用于A型血友病成人和儿童患者：（1）出血事件的预防和治疗；（2）围手术期管理；（3）常规预防措施，以防止或减少出血发作的频率。   2.  试验目的评估turoct

1. 试验药物简介

Turoctocog alpha（商品名NovoEight）是第三代重组凝血因子VIII，用于A型血友病患者出血事件的预防和治疗。2013年10月FDA批准NovoEight用于A型血友病成人和儿童患者：（1）出血事件的预防和治疗；（2）围手术期管理；（3）常规预防措施，以防止或减少出血发作的频率。

2. 试验目的

评估turoctocog alfa对于患血友病A的儿童中之前未治疗过的患者的安全性。

3. 试验设计

试验分类：安全性和有效性

试验分期： III期

设计类型：单臂试验

随机化：非随机化

盲法：开放

试验范围：国际多中心试验

试验人数：中国7人

4. 入选标准（必须全部符合）

1 在进行任何试验相关操作之前，必须签署知情同意书（试验相关操作指任何在患者的常规治疗期间不会进行的操作）

2 男性，诊断为遗传性重型血友病A患者（FVIII水平小于等于1%）

3 年龄<6岁

4 之前没有使用过纯化的凝血因子FVIII产品（以下暴露可以接受：使用血液成分制品，例如冷沉淀物，新鲜的冰冻血浆小于等于5个暴露日）包括已经上市的NovoEight/Novoeight

5. 排除标准（必须全部不符合）

1 已知或可疑对仓鼠蛋白过敏或不能耐受试验药物或相关产品

2 之前参加过本试验，定义为在应用试验药物后退出

3 患有血友病A外的其它遗传性或获得性凝血功能异常

4 任何FVIII抑制物史

5 在试验过程中正在应用或计划应用免疫调节剂（例如静脉滴注免疫球蛋白（IVIG）、规律的全身性皮质类固醇治疗）

6. 医院和研究者信息

序号	机构名称	主要研究者	国家	省（州）	城市
1	北京儿童医院	吴润晖	中国	北京	北京
2	中国医学科学院血液病医院	杨仁池	中国	天津	天津
3	南方医科大学南方医院	孙竟	中国	广东	广州
4	中国医学科学院北京协和医院	赵永强	中国	北京	北京
5	浙江大学医学院附属儿童医院	徐卫群	中国	浙江	杭州
6	重庆医科大学附属儿童医院	苏庸春	中国	重庆	重庆

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#插入话题

插入图片

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2015-09-20 gao_jian4217

#CTO#

68 0
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2016-01-27 xiongliangxl

#ALF#

91 0
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2016-05-11 linlin2312

#ROC#

72 0
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2015-11-17 habb

#OCT#

82 0
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2015-12-17 ms1756883563247400

#安全性和有效性#

71 0
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2015-09-11 ms1260584454294838

#招募#

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