A Post Authorization Safety Surveillance Study of Xyntha in Usual Care Settings

Wyeth Research0 个研究点目标入组 12 人开始时间: 2015年4月10日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1. Male subjects >=12 years of age with hemophilia A.
•2. Subjects transitioned to Xyntha from ReFacto or other recombinant or plasma-derived FVIII replacement products.
•3. Treatment history of greater than (>) 150 exposure days (EDs) to any recombinant or plasma-derived FVIII replacement products prior to the Enrollment Visit.
•4. Negative inhibitor at screening or documentation of a negative inhibitor titer (less than (<) 0.6 BU) using the Nijmegen modification of the Bethesda assay (or alternative assay for FVIII inhibitor) obtained within 6 weeks or less prior to the signing of the informed consent/assent form except for subjects entering the study on immune tolerance induction therapy. If the Nijmegen modification of the Bethesda assay is not available to the investigative site, the site must indicate which assay method is being used in the study source documents.
•5. Documented Human immunodeficiency virus (HIV)-positive subjects must have Cluster of Differentiation 4 (CD4) count >200 per microliter (>200/µL) confirmed within 6 months prior to the Enrollment Visit.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of any bleeding disorder in addition to hemophilia A.
•2. Inhibitor titer of >=0.6 BU (preferably using the Nijmegen modification of the Bethesda assay) during the screening period except for subjects on immune tolerance induction therapy.
•3. Treatment with immunomodulatory therapy (e.g. intravenous immunoglobulin [IVIG], routine systemic corticosteroids, cyclosporins, anti-TNF agents) during the screening period.
•4. Treatment with any investigational agent or device within 30 days of the Enrollment Visit.
•5. Known hypersensitivity to hamster protein.
•6. Any condition(s) that compromises the subject’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; and expectation of poor compliance with study-related procedure).
•7. Unwilling or unable to follow the terms of the protocol.

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