Determination of Safety, Efficacy, and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 years of age or older Diagnosed with Severe Hemophilia A - GreenGeneF_P3

Green Cross Corporation0 个研究点目标入组 124 人开始时间: 2014年9月3日最近更新: 2015年4月7日

适应症

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•1.Male or female subjects age = 12 years at time of informed consent
•2.Body weight = 35 kg
•3.Diagnosed with severe hemophilia A. Subjects must have severe hemophilia A with baseline FVIII < 1%, <0.01 IU/mL
•4.Have = 150 previous exposure days to FVIII concentrates, as documented in the subject's medical records
•5.Subjects included in the on-demand treatment cohort must have a verifiable record of at least three bleeding episodes per month on average in the last 6 months prior to enrollment
•6.Negative assays for FVIII inhibitor at inclusion(<0.6BU Nijmegen assay)
•7.Negative assays for FVIII inhibitor in subject files(<0.6BU Nijmegen assay). No history of positive inhibitor is allowed
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 64
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Presence at Screening of FVIII inhibitor = 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory
•2.History of FVIII inhibitor of = 0.6 BU as measured using the Nijmegen
•modification of the Bethesda assay
•3.History of FVIII inhibitor = 1.0 BU if the subject has been tested routinely using the original Bethesda assay, or history of periods with low recovery and no response to Factor VIII treatment
•4.Demonstrated an inability to respond to conventional doses of FVIII therapy
•5.History of incremental recovery of Factor VIII <1.35% per IU/kg infused
•6.Hematological disorders or blood coagulation diseases(e.g., idiopathic thrombocytopenic purpura, von Willebrand disease, etc.) other than haemophilia A
•7.Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR>1.4, the presence of splenomegaly and/or spider aniomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices

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