EUCTR2009-016719-39-PL进行中（未招募）不适用
IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level =2%) Hemophilia B Who are Planned to Enter BAX 326 Study 250901 to investigate a New Recombinant FIX Concentrate - IMMUNINE Pre-Treatment Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •- Subject and/or legal representative has/have provided signed informed consent.
- •Subject is up to 64 years old at the time of screening.
- •Subject has severe (FIX level < 1%) or moderately severe (FIX level = 2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory.
- •Subject is previously treated with plasma-derived or recombinant FIX concentrate(s), cryoprecipitate or fresh frozen plasma (FFP) for approximately 100 - 150 exposure days (EDs) if > = 6 years old or 20-50 ED if < 6 years old and is planned to enter either the Study BAX326 pivotal or BAX 326 pediatric study. The number of EDs is derived from the subject’s treatment regimen and his/her bleeding pattern.
- •Subject is willing to receive prophylactic treatment for the duration of the study.
- •Subject is immunocompetent as evidenced by a CD4 count = 200 cells/mm.
- •Subject is human immunodeficiency virus (HIV) negative or is HIV+ with a viral load < 200 particles/µL, approximately <400,000 copies/mL.
- •If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
- •Subject/legal representative is willing and able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The subject has a detectable FIX inhibitor at screening, with a titer =0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
- •The subject has a history of FIX inhibitors with a titer = 0.6 BU (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening.
- •The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s).
- •The subject has evidence of a thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
- •Subject is scheduled for elective surgery, unless the surgery is medically required within the anticipated study period
- •The subject has an abnormal renal function (serum creatinine > 1.5 times the upper limit of normal [ULN]).
- •The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) exceeding the upper limit of normal hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- •The subject has active hepatic disease with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels = 5 times the upper limit of normal. During the study, subjects with chronic hepatitis B or C may have fluctuations of up to 5 times the upper limit of normal but will not require discontinuation.
- •The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia B.
- •The subject’s platelet count is < 100,000/mL.
- •The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject’s safety or compliance.
- •The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (eg, a-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
- •The subject is pregnant or lactating at the time of study enrollment.
- •The subject is unwilling to consider further participation in the BAX326 (rFIX) pivotal or pediatric study.
- •Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment.
- •The subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
研究者
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