NCT01105546

rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: Male
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemophilia A With Inhibitors

Interventions

Type	Name	Description
DRUG	recombinant activated factor VII	90 µg/kg/day i.v.
DRUG	recombinant activated factor VII	treatment of bleeding episodes with 270 µg/kg (first/single dose) or 90 µg/kg i.v. every 2-3 hours until bleeding resolution

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2010-04-16
• Last updated: 2013-04-08

Locations

15 sites across 6 countries: United States, France, Germany, Italy, Romania, Spain