Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243386
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2005-10-21
Brief Title:
Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free rAHF-PFM in Patients With Hemophilia A
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Advate Antihemophilic Factor Recombinant PlasmaAlbumin Free Method ADVATE rAHF-PFM A Phase 4 Study Comparing Two Prophylactic Regimens in Subjects With Severe or Moderately Severe Hemophilia A
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The primary purpose of this randomized two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis 20-40 IUkg every 48 6 hours actual dose determined by the investigator with that of alternate prophylaxis 20-80 IUkg every 72 6 hours actual dose determined by Baxter utilizing an algorithm and the patients pharmacokinetic data The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms Prophylactic treatment will last for a period of 12 months - 2 weeks
Detailed Description:
None
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