JPRN-jRCT2080221833已完成3 期
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children with Haemophilia B - Paradigm5
ovo Nordisk Pharma Ltd.0 个研究点目标入组 40 人开始时间: 2012年6月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- ot applicable 至 <= 12age old（—）
- 性别
- Male
入选标准
- •1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the patient)
- •2.Male patients with moderately severe or severe congenital haemophilia B with a FIX activity level<= 2% according to medical records
- •3.Age<= 12 years (until patient turns 13 years, at time of inclusion)
- •4.Body weight >=10 kg
- •5.History of at least 50 EDs to other FIX products
- •6.The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an eDiary, capable of conducting home treatment and otherwise able to follow trial procedures
排除标准
- •1.Known or suspected hypersensitivity to FIX, hamster protein or related products
- •2.Previous participation in this trial defined as withdrawal after administration of N9-GP
- •3.The receipt of any investigational medicinal product (IMP) within 30 days prior to enrolment into this trial
- •4.Documented diagnosis of obesity defined as body mass index (BMI) equal to or greater than the 95th percentile for age for children >=2 years
- •5.Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient/caregiver interviews
- •6.Current FIX inhibitors 0.6 BU (central laboratory)
- •7.Congenital or acquired coagulation disorder other than haemophilia B
- •8.Platelet count <50,000/uL at screening (local laboratory)
- •9.Alanine aminotransferase (ALT) >3 times the upper limit of normal reference ranges at screening (central laboratory)
- •10.Creatinine level 1.5 times above the upper normal limit of normal reference ranges at screening (central laboratory)
- •11.HIV positive, defined by medical records, and with a CD4+ lymphocyte count 200/L. If the patients HIV status is unknown or if negative HIV test results in medical records are older than one year, it should be tested at the screening visit. If the patient is HIV positive, the CD4+ lymphocyte count must be tested
- •12.Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
- •13.Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
- •14.Any disease or condition which, according to the investigators judgment, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
- •15.Unwillingness, language or other barriers precluding adequate understanding and/or cooperation from patients and parent(s)
研究者
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