A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings

Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company0 个研究点目标入组 300 人开始时间: 2009年4月14日最近更新: 2013年10月14日

试验速览

暂无简介。

•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. 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.
•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

•1. Presence of any bleeding disorder in addition to hemophilia A.
•2. For laboratory assessment, any measured Bethesda inhibitor titer =0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer >ULN for the testing laboratory at the time of screening.
•3. Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
•4. Prior exposure to moroctocog alfa (AF-CC).
•5. Treatment with any investigational agent or device within 30 days before the Enrollment visit.
•6. Known hypersensitivity to hamster protein.
•7. 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).
•8. Unwilling or unable to follow the terms of the protocol.

发起方

Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company