Brief Title
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Official Title
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A
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 untreated children with haemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence Rate of Factor VIII Inhibitors (Above or Equal to 0.6 BU (Bethesda Units)/mL) for the Main Phase of the Trial
Secondary Outcome
Haemostatic Effect of Turoctocog Alfa on Treatment of Bleeds Assessed on a Predefined Four Point Scale: Excellent, Good, Moderate and None
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
turoctocog alfa
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
60
Start Date
September 17, 2012
Completion Date
December 5, 2018
Primary Completion Date
August 16, 2017
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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)
Gender
Male
Ages
0 Years - 6 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Algeria
Location Countries
Algeria
Administrative Informations
NCT ID
NCT01493778
Organization ID
NN7008-3809
Secondary IDs
U1111-1119-6116
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
November 2020