EUCTR2010-022726-33-ES进行中（未招募）1 期
BAX 326 (factor IX recombinante): Estudio de continuación sobre la evaluación de seguridad, inmunogenicidad y eficacia hemostática en pacientes tratados previamente portadores de hemofilia B grave (nivel de FIX < 1 %) o moderadamente grave (nivel de FIX menor o igual a 2 %). BAX 326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, andHemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%)or Moderately Severe (FIX level 2%) Hemophilia B A Continuation Study - BAX 326 Continuation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •? The subject and/or legal representative has/have voluntartily
- •provided signed informed consent.
- •? Subject has completed Baxter clinical study 250901.
- •? Subject was 12 to 65 years old at the time of screening for 250901
- •? 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
- •Identificador del archivo XML: /xlb8/CiHXFzSOSA4ydRpSmGIpU=
- •Página 16 de 29
- •laboratory.
- •? Subject has not developed an inhibitory FIX antibody during Baxter
- •clinical study 250901.
- •? Subject is human immunodeficiency (HIV) negative or is HIV+ with a
- •viral load < 200 particles/?L ~ <400,000 copies/mL
- •? Subject is immunocompetent as evidenced by a CD4 count ? 200
- •cells/mm3.
- •? If female of childbearing potential, subject presents with a negative
- •pregnancy test and agrees to continue employing adequate birth control
- •measures for the duration of the study.
- •? Subject is willing and able to comply with the requirements of the
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? The subject received factor IX product(s) other than BAX 326 upon
- •completion of Baxter pivotal study 250901.
- •? The subject has been diagnosed with an acquired hemostatic defect
- •other than hemophilia B.
- •? The subject's weight is < 35 kg or > 120 kg.
- •? The subject's platelet count is < 100,000/mL.
- •? The subject has an abnormal renal function (serum creatinine > 1.5
- •times the upper limit of normal).
- •? The subject has active hepatic disease with alanine aminotransferase
- •(ALT) or aspartate aminotransferase (AST) levels ? 5 times the upper
- •limit of normal.
- •? The subject is scheduled to receive during the course of the study, an
- •immunomodulating drug (e.g. corticosteroid agents at a dose equivalent
- •to hydrocortisone greater than 10 mg/day, or ?-interferon) other than
- •anti-retroviral chemotherapy.
- •? 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 planned to take part in any other clinical study, with the
- •exception of BAX 326 Surgery study as described in this protocol, during
- •the course of the Continuation Study.
- •? 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 (i.e., 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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