Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)
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'
Number of bleeding episodes (efficacy after administration)
Occurrence of antibodies to factor IX
human coagulation Factor IX
Study Arms / Comparison Groups
Description: The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
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
6 Years - N/A
Accepts Healthy Volunteers
E P Mauser-Bunschoten, MD, PdD, ,
E P Mauser-Bunschoten, MD, PdD, Principal Investigator, UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands