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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Dr. Lambert
Le kremlin Bicetre, , 94275 France
Contact
1-800-718-1021
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 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 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 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

NCT00749476
Pfizer
Completed
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX

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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Male
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00749476
3090X1-4405
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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