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

Last updated on March 14, 2019

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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.
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- 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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