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

NCT00749476

Last updated date
Study Location
Dr. Lambert
Le kremlin Bicetre, , 94275, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Hemophilia B
Intervention  ICMJE Biological: Factor IX recovery
Study Arms  ICMJE Experimental: 1
Intervention: Biological: Factor IX recovery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2010)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2008)
20
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00749476
Other Study ID Numbers  ICMJE 3090X1-4405
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2011

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