Status:
COMPLETED
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
Up to 11 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8))...
Eligibility Criteria
Inclusion
- Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
- Age below 12 years and weight at least 11 kg
Exclusion
- Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
- Congenital or acquired coagulation disorders other than haemophilia A
- Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01138501
Start Date
June 1 2010
End Date
November 1 2011
Last Update
March 17 2017
Active Locations (38)
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1
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
2
Novo Nordisk Investigational Site
Orange, California, United States, 92868
3
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004
4
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607