Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacy of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously untreated patients with haemophilia B (FIX activity =2%) - paradigm™6

ovo Nordisk A/S0 个研究点目标入组 50 人开始时间: 2015年6月9日最近更新: 2019年6月30日

适应症

试验速览

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, < 6 years of age at the time of signing informed consent
•- Patients with the diagnosis of haemophilia B (FIX activity level = 2%) based on medical records or central laboratory results
•- Previously untreated or exposed to FIX containing products less than or equal to 3 exposure days (5 previous exposure days to blood components are acceptable)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•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 FIX inhibitors (defined by medical records)
•- Known or suspected hypersensitivity to trial product or related products
•- Previous participation in this trial. Participation is defined as first dose administered of trial product
•- Receipt of any investigational medicinal product within 30 days before screening
•- Congenital or acquired coagulation disorder other than haemophilia B
•- 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)/LAR(s) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

发起方