NCT02020369

Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: rEVO Biologics · Industry
• Sex: Male
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This was a global, multicenter, Phase III, prospective, open-label, randomized, crossover study. After obtaining informed consent and performance of screening procedures, patients who met all inclusion and exclusion criteria were randomized to one of two treatment regimens as follows: * 75 µg/kg treatment regimen * 225 µg/kg treatment regimen For each treatment regimen there were two phases: * Phase A (Initial phase) * Phase B (Treatment phase) The assigned treatment regimen was the dose administered in Phase A and was the starting dose in Phase B.

Conditions

• Hemophilia A With Inhibitors
• Hemophilia B With Inhibitors

Interventions

Type	Name	Description
BIOLOGICAL	Coagulation Factor VIIa (Recombinant)	A cross over design to assess the efficacy 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

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2013-12-24
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

17 sites across 10 countries: United States, Belarus, Bulgaria, Georgia, Israel, Poland, Romania, Russia, Ukraine, United Kingdom