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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00749476

First received: September 8, 2008

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2008

Last Updated Date

June 6, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants Reporting Efficacy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient, biological efficacy just before and just after transition, BeneFix safety data after transition [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00749476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Convenience evaluation with PdFIX then with BeneFIX [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hemophilia B

Intervention ^ICMJE

Biological: Factor IX recovery

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

January 2009

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

Gender

Male

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00749476

Other Study ID Numbers ^ICMJE

3090X1-4405

Has Data Monitoring Committee

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 Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

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

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