Brief Title
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Participants Reporting Efficacy
Condition
Hemophilia B
Intervention
Factor IX recovery
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1
Start Date
April 2008
Completion Date
January 2009
Primary Completion Date
January 2009
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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00749476
Organization ID
3090X1-4405
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
June 2011