A Randomized, Multicenter, Double blind, Single doses Study Comparing the Pharmacodynamic, Pharmacokinetic and Safety of Biosimilar EPTACOG Alfa with Novoseven®, in Patient with Hemophilia A or B with Inhibitors

AryoGen Pharmed0 个研究点目标入组 48 人开始时间: 待定最近更新: 2022年3月8日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of congenital haemophilia A or B with inhibitors to FVIII or FIX titer >5 Bethesda Units [BU]
•-With > 2 episodes of bleeding/year requiring treatment with FVII infusions, non in bleeding episode
•-Male 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.
•-For the PK/PD phase, patients will be hospitalized at time of study medication administration for plasma sampling (2 times during the study).

•-Any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
•-Antibodies against Factor VII.
•-Ongoing bleeding prophylaxis regimens with Novoseven or planned to occur during the trial.
•-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).
•-Platelet count less than 100.000 platelets/mcL (at screening visit).
•-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.
•-Factor VIII/IX immune tolerance induction regimen planned to occur during the trial.
•-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