Status:
COMPLETED
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
Up to 6 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untrea...
Eligibility Criteria
Inclusion
- Age below 6 years
- Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
- Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
- No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®
Exclusion
- Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
- Previous participation in this trial defined as withdrawal after administration of trial product
- Congenital or acquired coagulation disorders other than haemophilia A
- Any history of Factor VIII inhibitor
- Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)
Key Trial Info
Start Date :
September 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01493778
Start Date
September 17 2012
End Date
December 5 2018
Last Update
November 30 2020
Active Locations (69)
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1
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
2
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
3
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
4
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States, 20010-2978