Status:
COMPLETED
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinan...
Eligibility Criteria
Inclusion
- Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
- Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
- No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)
Exclusion
- Congenital or acquired coagulation disorders other than haemophilia A
- Creatinine levels 50% above normal level (as defined by central laboratory range)
- Known or suspected allergy to trial product (N8) or related products
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00840086
Start Date
April 1 2009
End Date
September 1 2011
Last Update
March 17 2017
Active Locations (63)
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1
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72202
2
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
3
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
4
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322