Status:
COMPLETED
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Eligibility:
MALE
Brief Summary
This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant ...
Eligibility Criteria
Inclusion
- Diagnosed with haemophilia A or B with inhibitors
- Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed activated recombinant human factor VII
- Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities
- Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn)
Exclusion
- Known hypersensitivity to the active substance or the excipients in the formulation of activated recombinant human factor VII, or to mouse, hamster or bovine protein
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00703911
Start Date
March 1 2008
End Date
July 1 2010
Last Update
January 11 2017
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Algiers, Algeria, 16035
2
Novo Nordisk Investigational Site
Vienna, Austria, A-1010
3
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
4
Novo Nordisk Investigational Site
Prague, Czechia, 16000