Clinical Trial: Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor
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 Summary: 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 CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'
Sponsor: Sanquin
Current Primary Outcome:
- Number of bleeding episodes (efficacy after administration) [ Time Frame: 24 months ]
- Haematological variables and clinical chemistry (safety) [ Time Frame: 24 months ]
- Adverse events (safety) [ Time Frame: 24 months ]
Original Primary Outcome:
- Number of bleeding episodes (efficacy after administration)
- Haematological variables and clinical chemistry (safety)
- Adverse events (safety)
Current Secondary Outcome: Occurrence of antibodies to factor IX [ Time Frame: 24 months ]
Original Secondary Outcome: Occurrence of antibodies to factor IX
Information By: Sanquin
Dates:
Date Received: August 30, 2005
Date Started: May 2003
Date Completion:
Last Updated: August 29, 2007
Last Verified: August 2007
