Status:
COMPLETED
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
12-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia ...
Eligibility Criteria
Inclusion
- Severe haemophilia A (FVIII level less than or equal to 1%)
- Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
- HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
Exclusion
- Presence of any bleeding disorder in addition to haemophilia A
- Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
- Abnormal renal function tests
- Known hypersensitivity to Advate®
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00837356
Start Date
March 1 2009
End Date
October 1 2009
Last Update
February 10 2017
Active Locations (7)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 10249
2
Novo Nordisk Investigational Site
Hanover, Germany, 30625
3
Novo Nordisk Investigational Site
Tel Litwinsky, Israel, 52621
4
Novo Nordisk Investigational Site
Florence, Italy, 50134