AzTrials
AzTrials

Hemophilia BNCT00167973

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

An observational study of Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer at 90 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hemophilia B
How many people
218 participants
Where
90 sitesin 10 countries
Study dates
Jan 2002to Jun 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All EU patients beginning treatment with BeneFIX

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

90 sites in 10 countries.

90 sites in 10 countries

France24 sites

  • Study site

    Amiens, 80 80054

  • Study site

    Angers, 49 49033

  • Study site

    Caen, 14 14033

  • Study site

    Chambéry, 73 73011

  • Study site

    Grenoble, 38 38043

  • Study site

    Le Chesnay, 78 78153

  • Study site

    Le Kremlin-Bicêtre, 94 94279

  • Study site

    Liffré, 35 35340

  • Study site

    Limoges, 87 87042

  • Study site

    Lyon, 03 69437

  • Study site

    Lyon, 69 69000

  • Study site

    Marseille, 13 13385

  • Study site

    Montmorency, 95 95160

  • Study site

    Montpellier, 34 34059

  • Study site

    Montpellier, 34 34295

  • Study site

    Nantes, 44 44093

  • Study site

    Nevers, 58 58020

  • Study site

    Nice, 06 06202

  • Study site

    Osséja, 66 66344

  • Study site

    Paris, 75 75674

  • Study site

    Paris, 75 75743

  • Study site

    Rouen, 76 76031

  • Study site

    Saint-Priest-en-Jarez, 42 42270

  • Study site

    Tours, 37 37044

Other trials in France

United Kingdom18 sites

  • Study site

    Birmingham, Wstmid, B4 6NL

  • Study site

    Cardiff, W Glam, CF4 4XW

  • Study site

    Edinburgh, Loth, EH16 4SA

  • Study site

    Leeds, Wyorks, L59 7FF

  • Study site

    Liverpool, Mersyd, L12 2AP

  • Study site

    London, Gt Lon, SE13 6LH

  • Study site

    London, Gt Lon, W12 0HS

  • Study site

    London, Gt Lon, WC1N 3JH

  • Study site

    London, E1 1BB

  • Study site

    Manchester, Gt Man, M27 4HA

  • Study site

    Oxford, Oxon, OX3 L7J

  • Study site

    Plymouth

  • Study site

    Poole, BH15 2JB

  • Study site

    Sheffield, Mersyd, L12 2AP

  • Study site

    Sheffield, Syorks, S10 2TH

  • Study site

    Sheffield, S10 2JF

  • Study site

    Truro, Cnwll, TR1 3LJ

  • Study site

    Wolverhampton, Wstmid, WV10 0QP

Other trials in United Kingdom

Italy16 sites

  • Study site

    Ancona, AN, 60100

  • Study site

    Bari, BA, 70124

  • Study site

    Catania, CT, 95124

  • Study site

    Catanzaro, CZ, 88100

  • Study site

    Milan, MI, 20162

  • Study site

    Naples, 80131

  • Study site

    Padova

  • Study site

    Palermo, PA, 90134

  • Study site

    Palermo, 90100

  • Study site

    Parma, PR, 43100

  • Study site

    Perugia, 06126

  • Study site

    Pescara, PE, 65100

  • Study site

    Reggio Calabria, RC, 89100

  • Study site

    Roma, 00161

  • Study site

    Sassari, SS, 07100

  • Study site

    Vicenza, 36100

Other trials in Italy

Spain13 sites

  • Study site

    Almería, 04009

  • Study site

    Barcelona, 08035

  • Study site

    Burgos, 09005

  • Study site

    Cadiz, 11009

  • Study site

    Esplugues de Llobregat, 08950

  • Study site

    Madrid, 28046

  • Study site

    Mérida-Badajoz, 06800

  • Study site

    Santander, 38003

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46009

  • Study site

    Valladolid, 47010

  • Study site

    Vitoria-Gasteiz, 01004

  • Study site

    Zaragoza, 50009

Other trials in Spain

Belgium6 sites

  • Study site

    Brussels, 1020

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1200

  • Study site

    Edegem, 2650

  • Study site

    Leuven, 3000

  • Study site

    Montegnée, 4420

Other trials in Belgium

Netherlands6 sites

  • Study site

    Amsterdam, 1007 MB

  • Study site

    Breda, 4818 CK

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Maastricht, 6229 HX

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Utrecht, 3584 CX

Other trials in Netherlands

Germany3 sites

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Münster, North Rhine-Westphalia, 48143

Other trials in Germany

Sweden2 sites

  • Study site

    Malmö, 205 02

  • Study site

    Stockholm, 171 76

Other trials in Sweden

Austria1 site

  • Study site

    Vienna, 1090

Other trials in Austria

Portugal1 site

  • Study site

    Coimbra, 3000

Other trials in Portugal

About this study

Official title: 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.

Conditions
Hemophilia B
Keywords
Hemophilia B
Medical subject headings
Hemophilia B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observation for safety

    Measured: Study Duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167973
Sponsor's protocol ID
3090A-101039
Status last verified
May 2010
First submitted
11 Sep 2005
Last updated
26 May 2010
Results posted
No

Publications

  • 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.

    PubMed 26196195

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer at 90 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in France, United Kingdom, Italy, Spain, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observation for safety (time frame: Study Duration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00167973, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010.

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