EUCTR2008-006465-85-IT进行中（未招募）不适用
Pharmacokinetic evaluation of a new formulation of recombinant factor IX (BeneFIX) in the italian population with severe or moderate B haemophilia previously treated. - ND
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI0 个研究点开始时间: 2009年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1.Severe or moderate B haemophilia (factor IX activity < 5 %);
- •2.Male patients older than 6 years;
- •3.Patients previously treated with rFIX.
- •4.Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients ongoing treatment with plasmaderived factor IX (pd-FIX);
- •2.For patients with documented HIV infection, CD4 count <200 and/or in
- •HAART therapy;
- •3.Patients with liver or renal disease (ALT and AST 2.5x ULN, bilirubin >2
- •mg/dL, seric albumin <3.5 g/L seric creatinin >1.25 x ULN);
- •4.Prothrombin Time >1.5 x ULN;
- •5.Platelet count < 150.000/µL;
- •6.Patients with current or past inhibitors to factor IX;
- •7.Patients with history of hypersensitivity to FIX or to eccipients, or to Hamster proteins;
- •8 Exposure to other experimental drugs, eccept BeneFIX, in the 30 days prior to the sign of the informed consent of this study;
- •9.Patients with coagulation disorders/diseases different from B haemophilia;
- •10.Inflammatory disease documented and still present, which could, judjed by the investigator, be confounding the study results (e.g. systemic eritematosus lupus, rheumatoid arthritis, inflammatory bowel disease);
- •11.Patients showing low compliance to the study procedures, patients with difficult venous access, and all those patients who are judged (by the investigator) to be inadequate for this study.
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