EUCTR2009-016720-31-CZ进行中（未招募）不适用
BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level = 2%) Hemophilia B - BAX 326 pivotal
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
- 80
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 is 12 to 65 years old at the time of screening. Subject and/or legal representative has/have provided signed informed consent.
- •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 and/or recombinant FIX concentrate(s) for a minimum of 150 EDs (based on the subject’s medical records).
- •If a subject does not have a verifiable, documented history of 150 EDs, s/he can be enrolled if
- •1) there are 100 - 150 EDs to any FIX product (plasma-derived or recombinant FIX concentrate(s), cryoprecipitate, or fresh frozen plasma) that are not fully documented, and
- •2) s/he has participated in the Immunine protocol 050901 and accumulated either at least 50 EDs to Immunine or a total of at least 150 EDs to a plasma-derived and/or recombinant FIX concentrate prior to enrollment.
- •Subject has no evidence of a history of FIX inhibitors (based on the subject’s medical records). If a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment.
- •If the subject is willing to receive prophylactic treatment over a period of 6 months.
- •If the subject is willing to receive on-demand treatment, the subject has = 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment and is willing to receive on-demand treatment for the duration of participation in this study.
- •Subject is immunocompetent as evidenced by a CD4 count = 200 cells/mm3.
- •Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/µL ~ <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 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: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •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 history of FIX inhibitors with a titer = 0.6 Bethesda Units (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 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's weight is < 35kg or > 120 kg.
- •The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s).
- •The subject has a known hypersensitivity to hamster proteins or rFurin.
- •The subject has evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
- •The subject has an abnormal renal function (serum creatinine > 1.5 times the upper limit of normal).
- •The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4 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.
- •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 (eg, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or a-interferon) other than anti-retroviral chemotherapy.
- •The subject has participated in another investigational study within 30 days of enrollment. Participation in study 050901 with Immunine is allowed.
- •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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