An International, Multicenter, Prospective, Randomized, Single-blind, Parallel Design Study on the Efficacy and Safety of HemoRelÂ®-A Lyophilized for Intravenous Solution Versus the Registered Agent of Immunateâ?¢ Lyophilized for Intravenous Solution in Treatment and Prevention of Bleeding in Patients with Hemophilia A (Congenital Clotting Factor VIII Deficiency) or Acquired Coagulation Factor VIII Deficiency

Pharmasyntez JSC Russia0 个研究点目标入组 16 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Male patients with diagnosed hemophilia A or acquired clotting factor VIII deficiency
•2. Age of 18-65 years
•3. Informed consent form signed by the patient before any study procedures
•4. Capability of adhering to the prescribed procedures in the study, as the investigator thinks
•Additional inclusion criteria for the Phase 2a:
•5. A serious bleeding episode established and documented by the investigator

•1.Inconsistency with the inclusion criteria
•2.Patient is a military and / or an investigator and / or the family member of an investigator
•3.Patient has unstable hemodynamics, as the investigator thinks
•4.As the investigator thinks, bleeding which would be impossible to stop using of the study drug / comparator drug without the required use of other hemostatic agents and / or drugs
•5.As the investigator thinks, bleeding will stop on its own without the use of the study drug / comparator drug
•6.Neoplastic processes of any location
•7.Anamnestic indications to intolerance of the drug components
•8.The use of the drugs for hemophilia treatment within 6 hours prior to the study drug administration
•9.Presence of comorbid conditions that alter the natural course of the disease and influence the outcome of therapy, as the investigator thinks (blood diseases other than hemophilia A or acquired clotting factor VIII deficiency, infectious diseases, etc.)
•10.Alcoholism or alcohol abuse in the medical history
•11.Suspicion of a possible rule violation by the patient, as the investigator thinks
•12.Participation in another clinical trial within 30 days prior to the study drug administration

发起方

Pharmasyntez JSC Russia