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 Prophylaxis Phase IV

Baxter Innovations GmbH0 个研究点目标入组 66 人开始时间: 2006年1月25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 informed consent.
•2. The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level = 2% of normal, as tested at screening.iv
•3. The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant).
•4. The subject is within 7 to 65 years of age.
•5. The subject has a Karnofsky performance score > 60.
•6. The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a stable CD4 count = 400 cells/mm³ (CD4 count determined at screening if necessary). 7. The subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment.
•8. The subject has a documented history (e.g., in medical charts, dispensing information, or signed investigator statement) of at least 8 joint hemorrhages in the 12 months immediately prior to enrollment.
•9. The subject resides within the coverage area of the mobile compliance device (Section 12.6); 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 a history of factor VIII inhibitors with a titer = 0.6 BU (by Bethesda or Nijmegen assay) at any time prior to screening.
•3. The subject has a detectable factor VIII inhibitor at screening, with a titer = 0.4 BU (by Nijmegen Assay) in the central laboratory.
•4. The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
•5. The subject has been diagnosed with an inherited or acquired 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 sixty (60) days prior to or is being treated at screening/enrollment with an immunomodulating drug.
•7. The subject has participated in another investigational study within 30 days of enrollment.
•8. The subject has previously participated in a clinical study with ADVATE rAHF PFM. 9. The subject’s clinical condition may require a moderate or major surgery (i.e. requiring more study product than allowed by the protocol) during the period of the subject’s participation in the study. 10. The subject is female of childbearing potential with a positive pregnancy test.

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