Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166309
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-09-09
Brief Title:
The FEIBA NovoSeven Comparative Study
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
FENOC The FEIBA NovoSeven Comparative Study
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
FENOC is a prospective open-label randomized cross-over multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors The study is designed as a clinical equivalency trial
Detailed Description:
The incidence of inhibitors among people with severe hemophilia A has been documented as approximately 20-30 in several prospective studies In such patients acute hemorrhages frequently occur and profoundly jeopardize health with subsequent development of arthropathy A common way of treating such bleeding episodes is to use bypassing agents Among these agents the prothrombin complex concentrate FEIBA has been widely used for many years More recently recombinant factor VIIa NovoSeven has been added to the therapeutic options While both products have been found effective in treating hemorrhages the number of injections given for a bleeding episode has ranged widely and it is so far unknown whether one of the products might have a better effect in certain patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None