Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A
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)) in male previously treated paediatric subjects with haemophilia A.
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
Frequency of Adverse Events (AEs)
Congenital Bleeding Disorder
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - 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 Criteria: - 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)
N/A - 11 Years
Accepts Healthy Volunteers
Global Clinical Registry (GCR, 1452), ,
Novo Nordisk A/S
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S