NL-OMON50546招募中3 期
Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B - paradigm*6
ovo Nordisk0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •- 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)
排除标准
- •- 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
研究者
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