Clinical trial NCT00167973: Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
Official title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Keywords: Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 218
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All EU patients beginning treatment with BeneFIX

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Observation for safety
timeFrame: Study Duration
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Brussels
country: Belgium
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Montegnée
country: Belgium
city: Amiens Cedex
country: France
city: Angers Cedex 01
country: France
city: Caen Cedex
country: France
city: Chambery Cedex
country: France
city: Grenoble Cedex 09
country: France
city: Le Chesnay Cedex
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Liffre
country: France
city: Limoges
country: France
city: Lyon Cedex
country: France
city: Lyon
country: France
city: Marseille Cedex 5
country: France
city: Montmorency
country: France
city: Montpellier Cedex 5
country: France
city: Montpellier Cedex
country: France
city: Nantes Cedex
country: France
city: Nevers
country: France
city: Nice Cedex
country: France
city: Osseja Cedex
country: France
city: Paris Cedex 14
country: France
city: Paris Cedex 15
country: France
city: Rouen
country: France
city: Saint Priest en Jarez
country: France
city: St Priest en Jarez
country: France
city: Tours Cedex
country: France
city: Erlangen
country: Germany
state: BY
city: Hamburg
country: Germany
state: HH
city: Muenster
country: Germany
state: NW
city: Ancona
country: Italy
state: AN
city: Bari
country: Italy
state: BA
city: Catania
country: Italy
state: CT
city: Catanzaro
country: Italy
state: CZ
city: Milano
country: Italy
state: MI
city: Palermo
country: Italy
state: PA
city: Pescara
country: Italy
state: PE
city: Parma
country: Italy
state: PR
city: Reggio Calabria
country: Italy
state: RC
city: Sassari
country: Italy
state: SS
city: Napoli
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Perugia
country: Italy
city: Roma
country: Italy
city: Vicenza
country: Italy
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Eindhoven
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Utrecht
country: Netherlands
city: Coimbra
country: Portugal
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cadiz
country: Spain
city: Esplugues de Llobregat
country: Spain
city: Madrid
country: Spain
city: Mérida-Badajoz
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Vitoria
country: Spain
city: Zaragoza
country: Spain
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Truro
country: United Kingdom
state: Cnwll
city: London
country: United Kingdom
state: Gt Lon
city: London
country: United Kingdom
state: Gt Lon
city: London
country: United Kingdom
state: Gt Lon
city: Manchester
country: United Kingdom
state: Gt Man
city: Edinburgh
country: United Kingdom
state: Loth
city: Liverpool
country: United Kingdom
state: Mersyd
city: Sheffield
country: United Kingdom
state: Mersyd
city: Oxford
country: United Kingdom
state: Oxon
city: Sheffield
country: United Kingdom
state: Syorks
city: Cardiff
country: United Kingdom
state: W Glam
city: Birmingham
country: United Kingdom
state: Wstmid
city: Wolverhampton
country: United Kingdom
state: Wstmid
city: Leeds
country: United Kingdom
state: Wyorks
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Poole
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial mANAGER
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.