Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
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.
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'
Inclusion Criteria:

 -  Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers
 of Haemophilia B and Haemophilia B Leyden

 -  Above the age of six, at the moment of inclusion

 -  Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and
 negative for HBsAg

 -  Informed consent signed by the patients or his legally accepted representative

 Exclusion Criteria:

 -  Under the age of six, at the moment of inclusion

 -  Tested negative for HAV and HBV antibodies