Brief Title
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
Official Title
A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A
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)) in male previously treated paediatric subjects with haemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
Secondary Outcome
Frequency of Adverse Events (AEs)
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
rFVIII
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
June 2010
Completion Date
November 2011
Primary Completion Date
November 2011
Eligibility Criteria
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)
Gender
Male
Ages
N/A - 11 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01138501
Organization ID
NN7008-3545
Secondary IDs
U1111-1113-7182
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
February 2017