Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (Advate rAHF?PFM): A Phase 4 Study Comparing Two Prophylactic Regimens In Subjects With Severe Or Moderately Severe Hemophilia A. - ADVATE: A Phase IV Prophylactic Study

BAXTER AG0 个研究点目标入组 66 人开始时间: 2009年3月23日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•1.The subject or the subject`s legally authorized representative has provided written IC 2.the subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level < or = 2% of normal, as tested at screening 3. the subject has a documented history of at least 150 exposure days to factor VIII concentrates. 4. The subject is within 7 to 65 years of age. 5.the subject has a Karnofsky performance score >60 6.the subject is HIV- or is HIV+ with a CD4 count> or = 400 cells/mm3 7.The subject has been under the care of the study site for at least 24 months prior to enrollment 8.the subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment. 9. the subject has a documented history of at least 12 joint hemorrhages in the 12 months immediately prior to enrollment. 10. the subject resides within the coverage area of the mobile compliance device, coverage area will be determined at 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

•1.the subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins 2.The subject has an history of factor VIII inhibitors with a titer > or = 0.6 BU at any time prior to screening. 3.the subject has a detectable factor VIII inhibitor at screening with a titer > or = 0,4 BU in the central laboratory. 4.the subject has severe chronic liver disease as evidenced by INR>1.4, hypoalbuminemia, portal vein hypertension and hystory of esophageal varices. 5.has been diagnosed with an inherited or aquired hemostatic defect other than hemophilia A (e. g. qualitative platelet defect or von Willebrand`s Disease) 6.the subject has been treated during the last 60 days prior to or is being treated at screening/enrollment with an immunomodulating drug. 7.has participated in another investigational study within 30 days of enrollment 8. has previously participated in a clinical study with ADVATE rAHF-PFM. 9.his/her clinical conditions may require a moderate or major surgery during the period of his/her participation in the study (estimated blood loss > or = 500 ml). 10.the subject is female of childbearing potential with a positive pregnancy test.

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