EUCTR2010-022726-33-GB进行中（未招募）1 期
BAX 326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level = 2%) Hemophilia B – A Continuation Study. - BAX 326 Continuation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
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
- •The subject and/or legal representative has/have voluntarily provided signed informed consent.
- •The subject has completed Baxter Pivotal Study 250901 or Pediatric Study 251101.
- •The subject was aged 12 to 65 years old at the time of screening for 250901 or <12 years old at the time of screening for Pediatric Study 251101.
- •The subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101.
- •The subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/µL ~ < 400,000 copies/mL.
- •The 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.
- •The subject 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: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •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 protocol 250901 or Pediatric Study 251101.
- •The subject has been diagnosed with an acquired hemostatic defect other than hemophilia B.
- •For subjects transferring from Pivotal Study 250901: The subject’s weight is < 35 kg or > 120 kg.
- •4. 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 a-interferon) other than antiretroviral
- •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
研究者
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