Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157040
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2005-09-08
Brief Title:
Study of Pharmacokinetics Efficacy and Safety of a Recombinant and Protein-Free Factor VIII rAHF-PFM in Pediatric Patients With Hemophilia A
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Recombinant Antihemophilic Factor rAHF-PFM Manufactured and Formulated Without Added Human or Animal Proteins Evaluation of Pharmacokinetics Immunogenicity Efficacy and Safety in Previously Treated Pediatric Patients With 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 purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A The study consists of 2 parts Part 1 of the study is a pharmacokinetic evaluation and Part 2 is an evaluation of efficacy and safety
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