Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
1 other identifier
observational
218
10 countries
90
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2002
Longer than P75 for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMay 26, 2010
May 1, 2010
7.4 years
September 11, 2005
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observation for safety
Study Duration
Eligibility Criteria
All EU patients beginning treatment with BeneFIX
You may qualify if:
- Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Unknown Facility
Vienna, 1090, Austria
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Brussels, 1020, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Montegnée, 4420, Belgium
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Amiens, 80 80054, France
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Angers, 49 49033, France
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Caen, 14 14033, France
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Chambéry, 73 73011, France
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Grenoble, 38 38043, France
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Le Chesnay, 78 78153, France
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Le Kremlin-Bicêtre, 94 94279, France
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Liffré, 35 35340, France
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Limoges, 87 87042, France
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Lyon, 03 69437, France
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Lyon, 69 69000, France
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Marseille, 13 13385, France
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Montmorency, 95 95160, France
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Montpellier, 34 34059, France
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Montpellier, 34 34295, France
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Nantes, 44 44093, France
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Nevers, 58 58020, France
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Nice, 06 06202, France
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Osséja, 66 66344, France
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Paris, 75 75674, France
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Paris, 75 75743, France
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Rouen, 76 76031, France
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Saint-Priest-en-Jarez, 42 42270, France
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Tours, 37 37044, France
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Erlangen, Bavaria, 91054, Germany
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Hamburg, Hamburg, 20246, Germany
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Münster, North Rhine-Westphalia, 48143, Germany
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Ancona, AN, 60100, Italy
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Bari, BA, 70124, Italy
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Catania, CT, 95124, Italy
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Catanzaro, CZ, 88100, Italy
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Milan, MI, 20162, Italy
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Palermo, PA, 90134, Italy
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Pescara, PE, 65100, Italy
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Parma, PR, 43100, Italy
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Reggio Calabria, RC, 89100, Italy
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Sassari, SS, 07100, Italy
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Napoli, 80131, Italy
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Padua, Italy
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Palermo, 90100, Italy
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Perugia, 06126, Italy
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Roma, 00161, Italy
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Vicenza, 36100, Italy
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Amsterdam, 1007 MB, Netherlands
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Utrecht, 3584 CX, Netherlands
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Coimbra, 3000, Portugal
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Almería, 04009, Spain
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Barcelona, 08035, Spain
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Burgos, 09005, Spain
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Cadiz, 11009, Spain
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Esplugues de Llobregat, 08950, Spain
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Madrid, 28046, Spain
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Mérida-Badajoz, 06800, Spain
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Santander, 38003, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Valladolid, 47010, Spain
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Vitoria-Gasteiz, 01004, Spain
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Zaragoza, 50009, Spain
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Malmo, 205 02, Sweden
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Stockholm, 171 76, Sweden
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Truro, Cnwll, TR1 3LJ, United Kingdom
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London, Gt Lon, SE13 6LH, United Kingdom
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London, Gt Lon, W12 0HS, United Kingdom
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London, Gt Lon, WC1N 3JH, United Kingdom
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Manchester, Gt Man, M27 4HA, United Kingdom
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Edinburgh, Loth, EH16 4SA, United Kingdom
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Liverpool, Mersyd, L12 2AP, United Kingdom
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Sheffield, Mersyd, L12 2AP, United Kingdom
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Oxford, Oxon, OX3 L7J, United Kingdom
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Sheffield, Syorks, S10 2TH, United Kingdom
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Cardiff, W Glam, CF4 4XW, United Kingdom
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Birmingham, Wstmid, B4 6NL, United Kingdom
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Wolverhampton, Wstmid, WV10 0QP, United Kingdom
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Leeds, Wyorks, L59 7FF, United Kingdom
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London, E1 1BB, United Kingdom
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Plymouth, United Kingdom
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Poole, BH15 2JB, United Kingdom
Unknown Facility
Sheffield, S10 2JF, United Kingdom
Related Publications (1)
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.
PMID: 26196195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial mANAGER
For Germany, MedInfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, descresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Belgium, trials-BEL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Netherlands, trials-NL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Sweden, MedInfoNord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Austria, WPVIMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For UK, ukmedinfo@wyeth.com
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 14, 2005
Study Start
January 1, 2002
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 26, 2010
Record last verified: 2010-05