EUCTR2013-003742-16-GB进行中（未招募）不适用
Pharmacokinetics, Safety and Efficacy of Recombinant Factor IX Product, IB1001, in Patients with Severe Hemophilia B
Cangene Europe Limited0 个研究点目标入组 18 人开始时间: 2013年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- All
入选标准
- •1. Age of at least 12 years
- •2. Body Mass Index of = 29, with a minimum body weight of 40 kg
- •3. Written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent (ICF)
- •4. Willingness to make the required study visits, and follow instructions while enrolled in the study (up to 12 months)
- •5. Severe (factor IX activity =2 U/dL) hemophilia B subjects with a minimum of 3 bleeding episodes
- •over the preceding 6 months or 6 bleeding episodes over the preceding 12 months prior to being placed on prophylaxis
- •6. Subjects must be on prophylaxis or switch to a prophylaxis regimen for the duration of the PK and Treatment/Continuation Phase of the study
- •7. Previously treated patients with a minimum of 150 exposure days to a factor IX preparation
- •8. Willingness to adhere to the 5-day washout of any factor IX replacement therapy prior to PK evaluations
- •9. Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents
- •10. Platelet count at least 150,000/mm3
- •11. Liver function: alanine transaminase (ALT) and aspartate transaminase (AST) =2 times the upper
- •limit of the normal range
- •12. Total bilirubin =1.5 times the upper limit of the normal range
- •13. Renal function: serum creatinine =1.25 times the upper limit of the normal range
- •14. Hemoglobin =7 g/dL at the time of the blood draw
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. History of factor IX inhibitor =0.6 Bethesda units (BU)
- •2. Existence of another coagulation disorder
- •3. Evidence of thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
- •4. Use of an investigational drug within 30 days prior to study entry
- •5. Previous use of IB1001
- •6. Use of medications that could impact hemostasis, such as aspirin
- •7. Hypersensitivity to the active substance or to any of the excipients in the investigational products
- •8. Known allergic reaction to hamster proteins
- •9. History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol
- •10. History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject’s ability to treat bleeding episodes with a factor IX product
研究者
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