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

May 25, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
  • Belgium
      • Brussel, Belgium, 1090
      • Brussels, Belgium, 1200
      • Bruxelles, Belgium, 1020
      • Edegem, Belgium, 2650
      • Leuven, Belgium, 3000
      • Montegnée, Belgium, 4420
  • France
      • Amiens Cedex, France, 80 80054
      • Angers Cedex 01, France, 49 49033
      • Caen Cedex, France, 14 14033
      • Chambery Cedex, France, 73 73011
      • Grenoble Cedex 09, France, 38 38043
      • Le Chesnay Cedex, France, 78 78153
      • Le Kremlin Bicetre Cedex, France, 94 94279
      • Liffre, France, 35 35340
      • Limoges, France, 87 87042
      • Lyon, France, 69 69000
      • Lyon Cedex, France, 03 69437
      • Marseille Cedex 5, France, 13 13385
      • Montmorency, France, 95 95160
      • Montpellier Cedex, France, 34 34059
      • Montpellier Cedex 5, France, 34 34295
      • Nantes Cedex, France, 44 44093
      • Nevers, France, 58 58020
      • Nice Cedex, France, 06 06202
      • Osseja Cedex, France, 66 66344
      • Paris Cedex 14, France, 75 75674
      • Paris Cedex 15, France, 75 75743
      • Rouen, France, 76 76031
      • Saint Priest en Jarez, France, 42 42270
      • St Priest en Jarez, France, 42 42270
      • Tours Cedex, France, 37 37044
  • Germany
    • BY
      • Erlangen, BY, Germany, 91054
    • HH
      • Hamburg, HH, Germany, 20246
    • NW
      • Muenster, NW, Germany, 48143
  • Italy
      • Napoli, Italy, 80131
      • Padova, Italy
      • Palermo, Italy, 90100
      • Perugia, Italy, 06126
      • Roma, Italy, 00161
      • Vicenza, Italy, 36100
    • AN
      • Ancona, AN, Italy, 60100
    • BA
      • Bari, BA, Italy, 70124
    • CT
      • Catania, CT, Italy, 95124
    • CZ
      • Catanzaro, CZ, Italy, 88100
    • MI
      • Milano, MI, Italy, 20162
    • PA
      • Palermo, PA, Italy, 90134
    • PE
      • Pescara, PE, Italy, 65100
    • PR
      • Parma, PR, Italy, 43100
    • RC
      • Reggio Calabria, RC, Italy, 89100
    • SS
      • Sassari, SS, Italy, 07100
  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
      • Breda, Netherlands, 4818 CK
      • Eindhoven, Netherlands, 5623 EJ
      • Maastricht, Netherlands, 6229 HX
      • Nijmegen, Netherlands, 6525 GA
      • Utrecht, Netherlands, 3584 CX
  • Portugal
      • Coimbra, Portugal, 3000
  • Spain
      • Almeria, Spain, 04009
      • Barcelona, Spain, 08035
      • Burgos, Spain, 09005
      • Cadiz, Spain, 11009
      • Esplugues de Llobregat, Spain, 08950
      • Madrid, Spain, 28046
      • Mérida-Badajoz, Spain, 06800
      • Santander, Spain, 38003
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46009
      • Valladolid, Spain, 47010
      • Vitoria, Spain, 01004
      • Zaragoza, Spain, 50009
  • Sweden
      • Malmö, Sweden, 205 02
      • Stockholm, Sweden, 171 76
  • United Kingdom
      • London, United Kingdom, E1 1BB
      • Plymouth, United Kingdom
      • Poole, United Kingdom, BH15 2JB
      • Sheffield, United Kingdom, S10 2JF
    • Cnwll
      • Truro, Cnwll, United Kingdom, TR1 3LJ
    • Gt Lon
      • London, Gt Lon, United Kingdom, SE13 6LH
      • London, Gt Lon, United Kingdom, W12 0HS
      • London, Gt Lon, United Kingdom, WC1N 3JH
    • Gt Man
      • Manchester, Gt Man, United Kingdom, M27 4HA
    • Loth
      • Edinburgh, Loth, United Kingdom, EH16 4SA
    • Mersyd
      • Liverpool, Mersyd, United Kingdom, L12 2AP
      • Sheffield, Mersyd, United Kingdom, L12 2AP
    • Oxon
      • Oxford, Oxon, United Kingdom, OX3 L7J
    • Syorks
      • Sheffield, Syorks, United Kingdom, S10 2TH
    • W Glam
      • Cardiff, W Glam, United Kingdom, CF4 4XW
    • Wstmid
      • Birmingham, Wstmid, United Kingdom, B4 6NL
      • Wolverhampton, Wstmid, United Kingdom, WV10 0QP
    • Wyorks
      • Leeds, Wyorks, United Kingdom, L59 7FF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All EU patients beginning treatment with BeneFIX

Description

Inclusion Criteria:

  • Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observation for safety
Time Frame: Study Duration
Study Duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Sweden, MedInfoNord@wyeth.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 26, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3090A-101039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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