NCT02448680

A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Laboratoire français de Fractionnement et de Biotechnologies · Industry
• Sex: Male
• Age: 11 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 or IX in 12 patients ( birth to \<6 years old), and 12 patients (≥6 years old to \<12 years old).

Detailed 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

Conditions

• Hemophilia A With Inhibitors
• Hemophilia B With Inhibitors

Interventions

Type	Name	Description
BIOLOGICAL	Coagulation FVIIa (Recombinant)	A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/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 Factor IX

Timeline

• Start date: 2015-12-07
• Primary completion: 2017-06-30
• Completion: 2017-08-30
• First posted: 2015-05-19
• Last updated: 2022-02-25
• Results posted: 2020-08-28

Locations

9 sites across 6 countries: United States, Bulgaria, Czechia, Georgia, South Africa, Ukraine