NCT01224808已完成3 期
An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Haemostatic efficacy
研究概览
简要总结
The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in Paediatric Subjects with Von Willebrand Disease) or Study CSLCT-BIO-08-54 (Assessment of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with Von Willebrand Disease).
- •The subject and/or his/her legal guardian understand(s) the nature of the study and has/have given written informed consent to participate in the study and is/are willing to comply with the protocol.
排除标准
- •Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCT-BIO-08-
- •Mental condition rendering the subject (or the subject's legal guardian) unable to understand the nature, scope and possible consequences of the study.
- •Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
- •Are not willing and/or not able to comply with the study requirements.
- •Employee at the study site, or spouse/partner or relative of the Investigator or Subinvestigators.
- •Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
- •Intention to become pregnant during the course of the study.
- •Pregnancy, or nursing mother.
结局指标
主要结局
Haemostatic efficacy
时间窗: Up to 32 months
次要结局
- Development of FVIII inhibitors(Up to 32 months)
- Frequency of Adverse events (AEs) per subject(32 months)
- Development of VWF inhibitors(Up to 32 months)
- Severity of AEs per subject(32 months)
- Causality of AEs per subject(32 months)
- Causality of AEs per infusion(32 months)
- Severity of AEs per infusion(32 months)
- Frequency of Adverse events (AEs) per infusion(32 months)
研究者
研究点 (6)
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