Brief Title
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Official Title
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)
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 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'
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of bleeding episodes (efficacy after administration)
Secondary Outcome
Occurrence of antibodies to factor IX
Condition
Hemophilia B
Intervention
human coagulation Factor IX
Study Arms / Comparison Groups
A
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
May 2003
Completion Date
February 2007
Eligibility Criteria
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
Gender
All
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
E P Mauser-Bunschoten, MD, PdD, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT00139828
Organization ID
KB2000.03
Study Sponsor
Prothya Biosolutions
Study Sponsor
E P Mauser-Bunschoten, MD, PdD, Principal Investigator, UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
Verification Date
August 2007