Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245297
Status:
COMPLETED
Last Update Posted:
2007-10-16
First Post:
2005-10-26
Brief Title:
Study of the Efficacy of Human Recombinant Factor VIII Kogenate FS Reconstituted in Pegylated Liposomes
Sponsor:
Recoly NV
Organization:
Recoly NV
Study Overview
Official Title:
A Patient-Blinded Randomized Comparative Multicenter Crossover Liposome Dose Finding Study of the Efficacy of Human Recombinant Factor VIII Kogenate FS Reconstituted in Pegylated Liposomes
Status:
COMPLETED
Status Verified Date:
2007-10
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:
Primary efficacy endpoint To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 221 126 or 42 mg of pegylated liposomes per kg bwt compared with standard formulation
Safety endpoint To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes
Safety endpoint To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes
Detailed Description:
Each subject will receive treatment for three bleeding episodes wash-in on demand injections followed by a minimum 4 day wash-out Following this each subject will be randomized to a specific treatment order Each order consists of four identical blocks In each block the following three injections will be given 1 One prophylactic treatment randomized solution for dissolution 2 and 3 Two standard on-demand treatments for a spontaneous bleeding episode standard Kogenate FS Each block will be followed by a four day wash-out In total each subject should receive 34x315 injections It is estimated that each subject will be in the study for about 4 months A treatment for a spontaneous bleeding episode may require more than one infusion
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