Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)

Study Overview
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Brief Summary
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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
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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'

Official Title
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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)

Conditions
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Hemophilia B

Intervention / Treatment
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* Drug: human coagulation Factor IX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>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<br> <br> * Other names: Nonafact;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding episodes (efficacy after administration) |  | 24 months | 
| Haematological variables and clinical chemistry (safety) |  | 24 months | 
| Adverse events (safety) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of antibodies to factor IX |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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factor IX, haemophilia B, Product Surveillance, Postmarketing, plasma products