EUCTR2008-007997-39-GR进行中（未招募）不适用
A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 300 人开始时间: 2009年10月22日最近更新:
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
- 300
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. Male patients =12 years of age with severe hemophilia A (FVIII:C <1%).
- •2. Treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products.
- •3. Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
- •4. Serum albumin = the lower limit of normal (LLN).
- •5. Platelet count =100,000/µL.
- •6. Prothrombin time (PT) =1.25 × ULN, or international normalized ratio (INR) =1.5
- •7. Documented HIV-positive patients must have CD4 count >200/µL and HIV viral load <200 particles/µL confirmed within 6 months prior to enrollment.
- •8. Documented HCV-positive patients should have HCV viral load <200 particles/µL confirmed within 6 months prior to enrollment.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of any bleeding disorder in addition to hemophilia A.
- •2. A positive FVIII inhibitor by the local laboratory at screening and confirmed by a central laboratory Bethesda inhibitor titer = 0.6 BU/mL by Nijmegen modification of the Bethesda assay.
- •3. Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
- •4. Treatment with any investigational agent or device within 30 days before the Enrollment visit.
- •5. Known hypersensitivity to hamster protein.
- •6. Any condition(s) that compromises the patient’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; inability to properly store study drug; expectation of poor compliance in study-related documentation).
- •7. Unwilling or unable to follow the terms of the protocol.
研究者
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