rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors — ENJOIH

Hemophilia A With Inhibitors Clinical Trial

Official title:
An Investigator-initiated Study on rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors - European Initiative to Prevent Joint Damage in Hemophilia A Children With Inhibitors

Status Active, not recruiting

Clinical Trial Summary

The study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop high-titer inhibitors.

Clinical Trial Description

This is a multicentre, randomised, controlled study designed to gain evidence of the advantage of the prophylactic, daily treatment with recombinant activated FVII as compared to the conventional on demand therapy in reducing the bleeding frequency and preserving the orthopaedic status in hemophilic children with inhibitors. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01105546
Study type	Interventional
Source	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	December 2010
Completion date	April 2014

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Withdrawn	`NCT03002480` - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography	N/A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