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Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

NCT ID: NCT00167973

Last Updated: 2010-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2009-06-30

Brief Summary

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This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

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Detailed Description

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Conditions

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Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial mANAGER

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Sweden, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Austria, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For UK, [email protected]

Locations

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Vienna, , Austria

Site Status

Brussels, , Belgium

Site Status

Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Montegnée, , Belgium

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Amiens, , France

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Angers, , France

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Caen, , France

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Chambéry, , France

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Grenoble, , France

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Le Chesnay, , France

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Le Kremlin-Bicêtre, , France

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Liffré, , France

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Limoges, , France

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Lyon, , France

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Lyon, , France

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Marseille, , France

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Montmorency, , France

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Montpellier, , France

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Montpellier, , France

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Nantes, , France

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Nevers, , France

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Nice, , France

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Osséja, , France

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Paris, , France

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Paris, , France

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Rouen, , France

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Saint-Priest-en-Jarez, , France

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Tours, , France

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Erlangen, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Münster, North Rhine-Westphalia, Germany

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Ancona, AN, Italy

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Bari, BA, Italy

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Catania, CT, Italy

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Catanzaro, CZ, Italy

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Milan, MI, Italy

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Palermo, PA, Italy

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Pescara, PE, Italy

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Parma, PR, Italy

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Reggio Calabria, RC, Italy

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Sassari, SS, Italy

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Napoli, , Italy

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Padua, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Roma, , Italy

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Vicenza, , Italy

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Eindhoven, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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Utrecht, , Netherlands

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Coimbra, , Portugal

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Almería, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Cadiz, , Spain

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Esplugues de Llobregat, , Spain

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Madrid, , Spain

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Mérida-Badajoz, , Spain

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Santander, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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Vitoria-Gasteiz, , Spain

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Zaragoza, , Spain

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Malmo, , Sweden

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Stockholm, , Sweden

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Truro, Cnwll, United Kingdom

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London, Gt Lon, United Kingdom

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London, Gt Lon, United Kingdom

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London, Gt Lon, United Kingdom

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Manchester, Gt Man, United Kingdom

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Edinburgh, Loth, United Kingdom

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Liverpool, Mersyd, United Kingdom

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Sheffield, Mersyd, United Kingdom

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Oxford, Oxon, United Kingdom

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Sheffield, Syorks, United Kingdom

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Cardiff, W Glam, United Kingdom

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Birmingham, Wstmid, United Kingdom

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Wolverhampton, Wstmid, United Kingdom

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Leeds, Wyorks, United Kingdom

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London, , United Kingdom

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Plymouth, , United Kingdom

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Poole, , United Kingdom

Site Status

Sheffield, , United Kingdom

Site Status

Countries

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Austria Belgium France Germany Italy Netherlands Portugal Spain Sweden United Kingdom

References

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Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.

Reference Type DERIVED
PMID: 26196195 (View on PubMed)

Other Identifiers

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3090A-101039

Identifier Type: -

Identifier Source: org_study_id

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