MedTrace Logo

rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

NCT01105546 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-04-08

No results posted yet for this study

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.

Conditions

  • Hemophilia A With Inhibitors

Interventions

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

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Elena Santagostino, MD, PhD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • United States
  • France
  • Germany
  • Italy
  • Romania
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01105546 on ClinicalTrials.gov