Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195221
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2005-09-12
Brief Title:
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Retrospective multicenter study in patients with hemophilia B This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate
Following informed consent and eligibility historical patient information including demographics allergy history hemophilia history frequency and severity of allergic reactions number of exposure days with products causing allergic reactions exposure days to blood products including FIX concentrates treatment for allergic reactions outcome of events any other adverse events occuring within 48 hours of onset of allergic reactions rechallenge and outcome switch to another FIX product if applicable and outcome current status of patient and results of any special studies eg skin or RAST testing alloantibody analyses ect will be collected
Following informed consent and eligibility historical patient information including demographics allergy history hemophilia history frequency and severity of allergic reactions number of exposure days with products causing allergic reactions exposure days to blood products including FIX concentrates treatment for allergic reactions outcome of events any other adverse events occuring within 48 hours of onset of allergic reactions rechallenge and outcome switch to another FIX product if applicable and outcome current status of patient and results of any special studies eg skin or RAST testing alloantibody analyses ect will be collected
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