Health Condition 1: null- Congenital (Hemophilia A) or Acquired Clotting Factor VIII deficiency
Conditions
Interventions
Intervention1: HemoRel®-A Lyophilized for Intravenous Solution: 1 vial contains Active Ingredient: coagulation factor VIII (500 IU), Excipients:Sodium Chloride ( 250 mmol),Sodium Citrate ( 10 mmol),G
Sponsors
Pharmasyntez JSC Russia
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the efficacy of HemoRel®-A versus the registered agent of Immunateâ?¢ in treatment and prevention of bleeding in patients with hemophilia A or acquired coagulation factor VIII deficiency 2.To assess the efficacy of the hemostasis: a.Excellent results (normal hemostasis meaning normal hemostasis) b.Satisfactory results (hemostasis parameters are slightly lower) c.Unsatisfactory results (hemostasis is significantly below the norm) Timepoint: For patients in stage 2a (Acute bleeding treatment), after drug administration For patients in stage 2b (Prevention of bleeding during surgery), after surgery and during hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of HemoRel®-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 based on the number of adverse eventsTimepoint: For patients in stage 2a (Acute bleeding treatment), after drug administration For patients in stage 2b (Prevention of bleeding during surgery), after surgery and during hospitalization 7 days after the last intake of the study drug or the last visit carried out | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed