EUCTR2005-005246-40-DE进行中（未招募）不适用
A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in Subjects with Severe Hemophilia B. - Prophylaxis Clinical Study
Wyeth Pharmaceuticals Inc. - Global Medical Affairs0 个研究点目标入组 35 人开始时间: 2007年4月4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
- 入组人数
- 35
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. Documented history of moderately severe or severe hemophilia B (FIX:C = 2%)
- •2. Male subjects, aged 6 years to 65 years.
- •3. Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening.
- •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. Subjects currently utilizing FIX primary prophylaxis
- •2. For documented HIV+ subjects, CD4 count <200
- •3. Subjects with hepatic or renal impairment (ALT and AST = 5xULN, bilirubin > 2mg/dL, serum albumin 1.25xULN)
- •4. Prothrombin time > 1.5xULN
- •5. Platelet count < 150,000/µL
- •6. Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months
- •7. Subjects for which major surgery or orthopedic surgery is planned within the duration of the participation in this study
- •8. Subjects with a past history of, or current FIX inhibitor, defined as >ULN of the reporting laboratory
- •9. Subjects with a known hypersensitivity to any FIX product or hamster protein
- •10. Exposure to any investigational drug, except for BeneFIX, or device within 30 days of providing consent/assent (as appropriate) for this study
- •11. Subjects with bleeding disorders other than hemophilia B
- •12. Documented concurrent inflammatory disease that in the investigator's judgment could confound the study results (eg: systemic lupus, rheumatoid arthritis or inflammatory bowel disease)
- •13. Subjects unwilling to adhere to the terms of this protocol
- •14. Subjects with poor venous access, or who are otherwise inappropriate candidates for this trial in the judgment of the investigator.
研究者
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