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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749476
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 29, 2010
Last Update Posted : June 8, 2011
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Hemophilia B Biological: Factor IX recovery Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 1 Biological: Factor IX recovery

Primary Outcome Measures :
  1. Number of Participants Reporting Efficacy [ Time Frame: 4 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749476

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Dr. Lambert
Le kremlin Bicetre, France, 94275
Pr Chambost
Marseille, France, 13385
Dr. Hassoun
Montmorency, France, 95160
Pr Schved
Montpellier, France, 34291
Dr. Rothschild
Paris, France, 75743
Dr. Duillet
Rennes, France, 35033
Dr. Borg
Rouen, France, 76031
Pr Gruel
Tours, France, 37044
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00749476     History of Changes
Other Study ID Numbers: 3090X1-4405
First Posted: September 9, 2008    Key Record Dates
Results First Posted: June 29, 2010
Last Update Posted: June 8, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked