Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162019
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2005-09-08
Brief Title:
Pharmacokinetics Efficacy and Safety Study of IMMUNATE SD Human Plasma-Derived Coagulation Factor VIII Concentrate in Hemophilia A Patients
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Phase 3 Prospective Multicenter Study to Evaluate the Pharmacokinetics Immunogenicity Safety and Efficacy of IMMUNATE Solvent Detergent IMMUNATE SD in Previously Treated Patients 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 purpose of this study is to evaluate whether IMMUNATE SD is effective and safe in the treatment of hemophilia A patients The study consists of 3 parts Part 1 is a pharmacokinetic comparison of IMMUNATE SD and its predecessor IMMUNATE Part 2 is an evaluation of efficacy and safety of IMMUNATE SD Part 3 is a pharmacokinetic study of IMMUNATE SD
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