A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa — PERSEPT2

Hemophilia A With Inhibitors Clinical Trial

Official title:
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

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

Clinical Trial Details

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

View Details

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Withdrawn	`NCT03002480` - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography	N/A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