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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-01-31

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.

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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.

Conditions

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Hemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Factor IX recovery

Intervention Type BIOLOGICAL

Interventions

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Factor IX recovery

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No