EUCTR2010-024190-39-GB进行中（未招募）1 期
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects with Hemophilia B
Aptevo Europe Limited0 个研究点目标入组 22 人开始时间: 2011年2月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
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) Subject’s parent or legal guardian must give written informed consent and be willing to make the required study visits and follow instructions while enrolled in the study. For subjects =7 years of age, assent will be obtained if required by the institution.
- •2) Severe (factor IX activity= 2 IU/dL) hemophilia B subjects on demand therapy with a minimum of 2 bleeding episodes requiring factor IX therapy over the preceding 6 months or 4 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern similar to that described above prior to starting prophylaxis. In children under 5 years of age, severity may be indicated by the occurrence of one or more joint bleeds at any point in the child’s history requiring infusion(s) to replace factor IX.
- •3) Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents
- •4) Previously treated subjects with a minimum of 50 exposure days to a factor IX preparation
- •5) Platelet count at least 150,000/mm3
- •6) Liver function: alanine transaminase and aspartate transaminase =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 approximately 6 months (50 exposure days)
- •10) Age =12 years
- •11) Hemoglobin =7 g/dL at the time of the screening blood draw
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •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
- •1) History of factor IX inhibitor = 0.6 Bethesda units
- •2) Existence of another coagulation disorder
- •3) Evidence of thrombotic disease, fibrinolysis, or disseminated intravascular coagulation
- •4) Use of an investigational drug within 30 days prior to study entry
- •5) On medications that could impact hemostasis, such as aspirin
- •6) 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
- •7) 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
- •8) Hypersensitivity to the active substance or to any of the excipients in the investigational products
- •9) Known allergic reaction to hamster proteins
- •10) In Poland children weighing < 17.5 kg are excluded
研究者
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