临床试验/NCT01876745

NCT01876745已完成不适用

A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 4 人开始时间: 2014年10月7日最近更新: 2017年7月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 4
试验地点: 1
主要终点: Therapy-related thrombosis

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
•All-treated patients in the registration period

排除标准

•Known or suspected allergy to study product(s) or related products
•Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria [The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied]
•Patients with a history of hypersensitivity to any of the product components

研究组 & 干预措施

NovoSeven® (activated recombinant factor VII)

干预措施: eptacog alfa (activated) (Drug)

结局指标

主要结局

Therapy-related thrombosis

时间窗: From onset of treatment until 6 hours after treatment onset

次要结局

Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate(Within 24 hours after surgery for surgery/delivery)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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