A Phase 4 interventional study of human coagulation Factor IX in Hemophilia B, sponsored by Prothya Biosolutions. Completed at 7 sites in Netherlands. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2007-08-30.
Sponsored by Prothya Biosolutions · Phase 4, Interventional, and Treatment
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'
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 12 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Prothya Biosolutions is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: human coagulation Factor IX
Also known as: Nonafact
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
Occurrence of antibodies to factor IX
Time frame: 24 months
This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Prothya Biosolutions