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临床试验/CTRI/2011/06/001832
CTRI/2011/06/001832已完成3 期

Study of Recombinant Factor IX Product,IB1001,in Previously Treated Pediatric Subject with Hemophilia B  - NI

Aptevo Bio Therapeutics LLC0 个研究点目标入组 22 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
22
研究概览入排标准研究者记录与标识符相似试验

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

入选标准

  • •1. Subjectâ??s parent or legal guardian must give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved 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. For subjects < 7 years of age, legal assent is not reasonable to obtain.
  • •2. Severe (factor IX activity <=2 IU/dL) hemophilia B subjects currently 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 above demonstrated 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 childâ??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 patients with a minimum of 50 exposure days to a factor IX preparation 8 of 48 Confidential and Proprietary
  • •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 approximately 6 months (50 exposures)
  • •10. Age <=12 years
  • •11. Hemoglobin >=7 g/dL at the time of the blood draw

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. 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 subjectâ??s ability to treat bleeding episodes with a factor IX product
  • •8. Hypersensitivity to the active substance or to any excipients in the investigational products
  • •9. Known allergic reaction to hamster proteins
  • •10. In Poland children weighing < 17.5 kg will be excluded

研究者

发起方
Aptevo Bio Therapeutics LLC

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IMMUNINE - A Clinical Study with IMMUNINE (A Purified Factor IXConcentrate Virus-Inactivated) in Previously Treated Patients withSevere or Moderately Severe Hemophilia B Who are Planned to Enter theBAX 326 Study (250901, Investigating a new Factor IX Product)to expose up to 50 patients aged 12-64 years, and approximately 20 patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 20 to 50 exposure days (EDs) prospectively document the exposure days (EDs) and development of factor IX (FIX) inhibitionors if any, while receiving prophylactic treatment so that these patients can transition into the BAX 326 pivotal or pediatric study evaluating a new rFIX.MedDRA version: 14.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disorders
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