Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX

Study Overview
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Brief Summary
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The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

Detailed Description
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The switch to BeneFIX has already been decided by the investigator. Patients will be followed up to 3 months after the switch.

Official Title
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Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

Conditions
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Hemophilia B

Intervention / Treatment
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* Biological: Factor IX recovery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderately to severe haemophilia B patient (FIX activity < or equal to 2%) for whom the switch from pdFIX to BeneFIX has already been decided by the investigator Previously treated patients (PTP) with > or equal to 150 ED to any FIX product Male patients, aged > or equal to 12 years Absolute CD4 count > or equal to 300/microL Normal platelet count (> or equal to 100 000/microL) Patient is in a non-bleeding state and has not received any coagulation FIX within five (5) days of recovery Written informed consent obtained prior to study entry (for patients aged < 18 years, parents' signature or subject legally acceptable representative obtained prior to study entry) Exclusion Criteria Any other known bleeding disorder in addition to haemophilia B History of, or current detectable factor IX inhibitor (> or equal to 0.6 BU by Bethesda inhibitor assay) History of anaphylaxis to any coagulation factor IX Patient with a known hypersensitivity to hamster protein Patient with a hypersensitivity to the active substance or to any of the excipients Patient unable to be off FIX replacement therapy for at least 5 days without bleeding Patient with hepatic or renal impairment (ALT [SGPT] and AST [SGOT] > 5 x Upper Limit Normal (ULN), total bilirubin > 20mg/l, albumin < 25 g/l, prothrombin time > 1.25 x ULN, serum creatinine > 1.25 x ULN) Treatment with any investigational drug or device within the past 30 days Any condition that, in the Investigator's judgment, makes participation in the study not advisable

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Male

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Factor IX recovery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Efficacy | Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion. | 4 months |