EUCTR2012-004867-38-IT进行中（未招募）1 期
Safety and efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophila B.An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacyof nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previouslyuntreated patients with haemophilia B (FIX activity =2%) - An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacy
OVO NORDISK. S.P.A.0 个研究点目标入组 50 人开始时间: 2018年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Informed consent obtained before any trial-related activities. Trialrelated
- •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: 1
- •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
排除标准
- •- Any history of FIX inhibitors (defined by medical records)
- •- Known or suspected hypersensitivity to trial product or related
- •- 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
- •- 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
- •- 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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