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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00749476
First received: September 8, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Hemophilia B
Biological: Factor IX recovery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Participants Reporting Efficacy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Factor IX recovery

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749476

Locations
France
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00749476     History of Changes
Other Study ID Numbers: 3090X1-4405
Study First Received: September 8, 2008
Results First Received: January 29, 2010
Last Updated: June 6, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on August 28, 2014