Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037557
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2002-05-17
Brief Title:
Study Evaluating rFIX BeneFIX in Severe 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:
An Open-Label Single-Arm Safety and Efficacy Study of Recombinant Human Factor IX rFIX BeneFIX in Children Less Than 6 Years of Age With Severe 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:
To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes prophylaxis andor surgery
This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed including inhibitor development thrombogenicity FIX recoverylack of effect allergic-type manifestations and RBC agglutination Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general
This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed including inhibitor development thrombogenicity FIX recoverylack of effect allergic-type manifestations and RBC agglutination Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general
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