EUCTR2007-005100-41-GB进行中（未招募）1 期
Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Haemophilia B
Aptevo Europe Limited0 个研究点目标入组 80 人开始时间: 2009年4月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •1. Patient must be willing to give written Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved informed consent, make the required study visits, and follow instructions while enrolled in the study.
- •2.Severe (factor IX activity =2 U/dL) hemophilia B subjects on-demand therapy with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern as above demonstrated prior to starting prophylaxis
- •3.Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents
- •4.Previously treated patients with a minimum of 150 exposure days to a factor IX preparation
- •5.Platelet count at least 150,000/mm3
- •6.Liver function: alanine transaminase [ALT] and aspartate transaminase [AST] =2 times the upper limit of the normal range
- •7.Total bilirubin =1.5 times the upper limit of the normal range
- •8.Renal function: serum creatinine =1.25 times the upper limit of the normal range
- •9.Willingness to participate in the trial for up to 12-15 months
- •10.European Union (EU), Israel, and India: Age of at least 12 years and body weight of =40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 12 years for the prophylaxis and on-demand components of the Treatment Phase and Continuation Study. Subjects in France less than 18 years of age will not be included in any PK study.
- •United States (US): Age of at least 12 years and body weight of =40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 5 years for the prophylaxis and on-demand components of the Treatment Phase and Continuation Study
- •11.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: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.On medications that could impact hemostasis, such as aspirin
- •6.Hypersensitivity to the active substance or to any of the excipients in the investigational products
- •7.Known allergic reaction to hamster proteins
- •8.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
- •9.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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