Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139828
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2005-08-30
Brief Title:
Post Marketing Study in Haemophilia B Patients Using Nonafact Human Coagulation Factor IX
Sponsor:
Prothya Biosolutions
Organization:
Prothya Biosolutions
Study Overview
Official Title:
Post Marketing Study in Haemophilia B Patients Using Nonafact 100 IUml Powder and Solvent for Solution for InjectionHuman Coagulation Factor IXHuman Plasma Derived Factor IX Product Freeze Dried
Status:
COMPLETED
Status Verified Date:
2007-08
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:
In this postmarketing study the safety of Nonafact human coagulation factor IX is evaluated in previous treated and untreated patients with severe moderate or mild haemophilia B
Detailed Description:
The clinical efficacy and safety of Nonafact has been shown in two pre-authorisation studies Marketing authorisation for the EU was granted 3 July 2001 The Post Marketing Study which evaluates the clinical efficacy immunogenicity and safety of Nonafact is set up according to CPMPBPWG 19895 rev 1 Final London 19 October 2000 Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products
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