Status:
COMPLETED
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia B
Eligibility:
MALE
12+ years
Phase:
PHASE4
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 th...
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
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00749476
Start Date
April 1 2008
End Date
January 1 2009
Last Update
June 8 2011
Active Locations (8)
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1
Dr. Lambert
Le Kremlin-Bicêtre, France, 94275
2
Pr Chambost
Marseille, France, 13385
3
Dr. Hassoun
Montmorency, France, 95160
4
Pr Schved
Montpellier, France, 34291