Phase 4
N=1
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Hemophilia B
Bottom Line
View on ClinicalTrials.gov: NCT00749476 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Jun 2010
Primary outcome: Primary: Number of Participants Reporting Efficacy
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Factor IX recovery (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Male
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Efficacy |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Moderately to severe haemophilia B patient (FIX activity 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 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
Data sourced from ClinicalTrials.gov (NCT00749476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.