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Clinical Trial Summary

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years old).


Clinical Trial Description

A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients from birth to <12 years old with Inhibitors to Factor VIII or IX: PerSept 2 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02448680
Study type Interventional
Source Laboratoire français de Fractionnement et de Biotechnologies
Contact
Status Completed
Phase Phase 3
Start date December 7, 2015
Completion date August 30, 2017

See also
  Status Clinical Trial Phase
Completed NCT00231751 - The Malmö International Brother Study (MIBS) N/A
Completed NCT00221195 - Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors Phase 2/Phase 3
Terminated NCT02484638 - Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors Phase 2/Phase 3
Terminated NCT00212472 - International Immune Tolerance Study N/A
Withdrawn NCT03002480 - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography N/A
Completed NCT03093480 - A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study) Phase 4
Active, not recruiting NCT01105546 - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors Phase 2
Completed NCT02020369 - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX Phase 3