Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Previously Untreated Patients with Haemophilia AAn open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacy of N8-GP in prophylaxis and treatment of bleeding episodes in previously untreated paediatric patients with severe haemophilia A - pathfinder™6

ovo Nordisk A/S0 个研究点目标入组 125 人开始时间: 2014年4月8日最近更新: 2017年10月2日

研究概览

暂无简介。

•- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•- Male, age < 6 years at the time of signing informed consent
•- Diagnosis of severe haemophilia A (factor VIII activity level < 1%) based on medical records or central laboratory results
•- No prior use of purified clotting factor products (5 previous exposure to blood components is acceptable)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 125
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Any history of FVIII inhibitor (defined by medical records)
•- Known or suspected hypersensitivity to trial product or related products
•- Previous participation in this trial. Participation is defined as administration of trial product
•- Receipt of any investigational medicinal product within 30 days before screening
•- Congenital or acquired coagulation disorder other than haemophilia A. Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient’s safety or compliance with the protocol.
•- Patient’s parent(s)/legally acceptable representative(s) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

发起方