Clinical trial NCT00749476: Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Official title: Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 1
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Efficacy
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le kremlin Bicetre
country: France
facility: Dr. Lambert
city: Marseille
country: France
facility: Pr Chambost
city: Montmorency
country: France
facility: Dr. Hassoun
city: Montpellier
country: France
facility: Pr Schved
city: Paris
country: France
facility: Dr. Rothschild
city: Rennes
country: France
facility: Dr. Duillet
city: Rouen
country: France
facility: Dr. Borg
city: Tours
country: France
facility: Pr Gruel
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: