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

Hemophilia B Clinical Trial

Official title:

Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749476
• Other study ID #: 3090X1-4405
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: June 6, 2011
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Biological:
• Factor IX recovery

Locations

Country	Name	City	State
France	Dr. Lambert	Le kremlin Bicetre
France	Pr Chambost	Marseille
France	Dr. Hassoun	Montmorency
France	Pr Schved	Montpellier
France	Dr. Rothschild	Paris
France	Dr. Duillet	Rennes
France	Dr. Borg	Rouen
France	Pr Gruel	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Efficacy	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.	4 months	Yes