EUCTR2009-016720-31-SE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 wtih Severe (FIX level < 1%) or Moderately Severe (FIX = 2 %) Hemphilia B - BAX 326 pivotal
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
- 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 = 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 150EDs, s/he can be enrolled if 1) there are 100-150EDs to any FIX product (plasma-derived or recombinant FIX concentrates(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 lease 50 EDs to Immunine or a total of at least 150 EDs to a plasma-derived and /or recombinant FIX concntrate 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 Sudy 050901 for at least 50 EDs to Immunine priot to enrollment.
- •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 greater than or equal to 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 greater than or equal to 200 cells/mm3.
- •Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load of < 200 particles/µL ~<4000,000 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 greater than or equal to 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 greater than or equal to 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
- •The subject's weight is <35 kg or > 120 kg.
- •The subject has a history of allergic reation, eg, anaphylaxis, following exposure to FIX concentrate(s).
- •The subject has known hypersensitivity to hamster proteins or rFurin.
- •The subject has evidence of an ongoin or recent thrombotic diease, fibrinolysis or disseminted intravasular coagulation (DIC).
- •The subject has an abnormal renal function (serum creatinine > 1.5 times the upper limit of normal).
- •The subject has sever chronic liver diease as evidenced by, but not limited to, any of the following: International Normalized Ration (INR) greater than 1.4 hypoalbuminemiaq, portal vein hypertension including presence of otherwise unexplained splenomegaly and histroy of esophageal varices.
- •The subject has active heptic disease with alanine aminotrasferase (ALT) or aspartate aminotransferase (AST) level greater than or equal to 2 times the upper limit of normal.
- •The subject has been diagnosed with an inherited or acquired hemostatic defict other than hempholia 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 subjec't 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 great than 10mg/day, or alpha-interferon) other than anti-retroviral chemotherapy.
- •The subject has participated in another investigational study within 30days 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 relationshep with one of the sutdy team members. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parent) as well as employees of the ivestigator or site personnel conducting the study.
研究者
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