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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/IX


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02020369
Study type Interventional
Source rEVO Biologics
Contact
Status Completed
Phase Phase 3
Start date April 2014
Completion date August 2015

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Withdrawn NCT03002480 - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography N/A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
Completed NCT02448680 - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa Phase 3
Active, not recruiting NCT01105546 - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors Phase 2