Safety and Efficacy of Turoctocog Alfa in Previously Treated Male 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 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.

Key facts

Study ID

NCT01138501

Run by

Novo Nordisk A/S

People needed

65

Starts

2010-06-01

Expected to finish

2011-11-01

Last updated by the study team

2017-03-17

Who can join

Age: any, up to 11. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
• Age below 12 years and weight at least 11 kg

You may not qualify if…

• 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)

Where it is running

• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Torrance, California, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — East Lansing, Michigan, United States
• Novo Nordisk Investigational Site — Kansas City, Missouri, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Valhalla, New York, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Charleston, South Carolina, United States
• Novo Nordisk Investigational Site — Fort Worth, Texas, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Curitiba, Paraná, Brazil
• Novo Nordisk Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novo Nordisk Investigational Site — Campinas, São Paulo, Brazil
• Novo Nordisk Investigational Site — São Paulo, São Paulo, Brazil
• Novo Nordisk Investigational Site — Milan, Italy
• Novo Nordisk Investigational Site — Shizuoka-shi, Shizuoka, Japan
• Novo Nordisk Investigational Site — Vilnius, Lithuania

Full record on ClinicalTrials.gov

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