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

September 8, 2008
June 6, 2011
April 2008
January 2009   (final data collection date for primary outcome measure)
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.
number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient, biological efficacy just before and just after transition, BeneFix safety data after transition [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00749476 on ClinicalTrials.gov Archive Site
Not Provided
Convenience evaluation with PdFIX then with BeneFIX [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Hemophilia B
Biological: Factor IX recovery
Experimental: 1
Intervention: Biological: Factor IX recovery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00749476
3090X1-4405
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP