Status:
COMPLETED
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Lead Sponsor:
Prothya Biosolutions
Conditions:
Hemophilia B
Eligibility:
All Genders
6+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- Under the age of six, at the moment of inclusion
- Tested negative for HAV and HBV antibodies
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00139828
Start Date
May 1 2003
End Date
February 1 2007
Last Update
August 30 2007
Active Locations (7)
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1
Academic Medical Centre
Amsterdam, Netherlands, 1105 AZ
2
Kennemer Gasthuis
Haarlem, Netherlands
3
LUMC
Leiden, Netherlands, 2333 ZA
4
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA