A Randomized, Multi-center, Single Dose, Cross over Study Comparing the Pharmacokinetic of Bio-similar EPTACOG Alfa with NOVOSEVEN®, in Patients with Congenital Factor VII Deficiency

AryoGen Pharmed0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年3月8日

适应症

试验速览

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•Patients with a confirmed diagnosis of congenital, severe Factor VII deficiency (FVII <1%), with >2 episodes of bleeding/year requiring treatment with FVII infusions, in non-bleeding status.
•Male and female subjects
•Adult and children (>12 years)
•Patients to be enrolled must also provide voluntary written informed consent to the protocol to be eligible for the study. For minor patients, parent/legal guardian will provide consent and, when possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent.
•Patients in the Pharmacokinetic (PK) phase will be hospitalized at time of study medication administration and plasma sampling (2 times during the study).

•Any other type of congenital or acquired coagulopathy (except congenital Factor VII deficiency), such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
•Antibodies against Factor VII
•Patients entering the PK Phase who have not suspended prophylactic regime with Novoseven or AryoSeven 3 days before starting the trial (receiving first dose of study medication).
•Platelet count less than 100.000 platelets/mcL (at screening visit)
•Patients who have received routine (prophylactic) treatment with rFVIIa in the period between screening visit (visit 1) and visit 2 of this study (first dose administration)
•Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
•HIV positive with current CD4+ count of less than 200/µL
•Liver cirrhosis
•Known hypersensitivity to the study medication
•Parallel participation in another experimental drug trial.
•Parallel participation in another marketed drug trial that may affect the primary end point of the study.

发起方