A randomized, two-armed, double-blind, single-dose, crossover, two sequence, active-controlled, multi-center, bioequivalence clinical trial to compare PK parameters and safety of Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) (Coageight, produced by AryoGen Pharmed Company (versus rFVIII-Fc (Elocta®, produced by Sobi Company) in previously treated patients with severe hemophilia A

AryoGen Company0 个研究点目标入组 50 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•Male patients = 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
•Diagnosed with severe hemophilia A (endogenous FVIII <1% [1 IU/dL])
•History of at least 150 documented prior exposure days to any FVIII product
•Having adequate bone marrow and organ function:•Plt = 80,000 cells/µL •Hgb = 8 mg/dL•eGFR = 30 mL/min•ALT or AST = 5×ULN•Serum bilirubin = 1.5×

•Measurable anti-drug antibody activity against FVIII (= 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
•History of other coagulation disorders except for hemophilia A
•Acute hemorrhagic state
•Infection with HCV or HBV
•HIV-positive patients
•Infusion of any products containing FVIII within 7 days prior to first administration
•Previous treatment with commercially available extended half-life products
•Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
•Current systemic treatment with immunosuppressive drugs
•Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIg)
•Planned elective surgery
•Current enrolment or willing to enroll in any other experimental study during the time of current trial
•Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)

发起方

AryoGen Company