Viewing Study NCT00189982



Ignite Creation Date: 2024-05-05 @ 11:56 AM
Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00189982
Status: COMPLETED
Last Update Posted: 2021-05-05
First Post: 2005-09-08

Brief Title: Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII rAHF-PFM in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101
Sponsor: Baxalta now part of Shire
Organization: Takeda

Study Overview

Official Title: Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins ADVATE rAHF-PFM Safety Monitoring in Pediatric Patients Diagnosed With Severe to Moderately Severe Hemophilia A - A Continuation of Baxter Clinical Study 060101
Status: COMPLETED
Status Verified Date: 2021-05
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 safe and effective in the treatment of children with hemophilia A The study is open to pediatric patients in Canada who completed Baxter Study 060101
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