PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY - Advate rAHF-PFM versus Recombinate rAHF

Baxter Innovations GmbH0 个研究点开始时间: 2007年11月30日最近更新: 2012年3月19日

试验速览

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•1.Signed informed consent obtained from subject or legally authorized representative
•2. Age 15 - 60 years
•3. Factor VIII level < 1% as documented by previously measured factor VIII and genotyping
•4. Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry.
•5. Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM.
•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

•1. A detectable factor VIII inhibitor with a titer = 0.4 BU based on the patient charts.
•2. The subject has a known hypersensitivity to mouse or hamster proteins or to either study product.
•3. The subject is participating in another investigational drug study within 30 days prior to screening.
•4. The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.

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