Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT01493778

Run by

Novo Nordisk A/S

People needed

60

Starts

2012-09-17

Expected to finish

2018-12-05

Last updated by the study team

2020-11-30

Who can join

Age: any, up to 6. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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®

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Sacramento, California, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Gainesville, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Macon, Georgia, United States
• Novo Nordisk Investigational Site — Savannah, Georgia, United States
• Novo Nordisk Investigational Site — Oak Lawn, Illinois, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States
• Novo Nordisk Investigational Site — New Brunswick, New Jersey, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Charlotte, North Carolina, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Oklahoma City, Oklahoma, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Charleston, South Carolina, United States
• Novo Nordisk Investigational Site — Salt Lake City, Utah, United States
• Novo Nordisk Investigational Site — Charlottesville, Virginia, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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