Clinical trial NCT00714415: Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
Official title: Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-14
Enrollment: 80
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: Patients with hemophilia B

Brief summary: The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

* Patients with hemophilia B treated with a product other than BeneFIX®.
* Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Number of Participants With Adverse Events (AEs) of Special Interest
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Investigator Assessment of Treatment Tolerability of Participants
timeFrame: End of study visit (any time up to 8.7 years)
measure: Participant Assessment of Treatment Tolerability
timeFrame: End of study visit (any time up to 8.7 years)
Secondary outcomes:
measure: Mean Total Number of Bleeding Episodes in Participants
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Mean Total Number of Bleeding Episodes Per Year in Participants
timeFrame: Baseline until last visit (up to 8.7 years)
measure: Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
timeFrame: Baseline, up to 8.7 years
measure: Investigator Assessment of Treatment Efficacy of Participants
timeFrame: End of study visit (any time up to 8.7 years)
measure: Investigator Assessment of Treatment Handling of Participants
timeFrame: End of study visit (any time up to 8.7 years)
measure: Assessment of Treatment Efficacy by the Participants
timeFrame: End of study visit (any time up to 8.7 years)
measure: Assessment of Treatment Handling by the Participants
timeFrame: End of study visit (any time up to 8.7 years)
measure: Investigator Assessment of Treatment Satisfaction of Participants
timeFrame: Baseline up to 8.7 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz, Kinderklinik
city: München
country: Germany
facility: Sonnengesundheitszentrum
state: Bayern
city: Hannover
country: Germany
facility: Werlhof-Institut für Haemostaseologie GmbH
state: Niedersachsen
city: Muenster
country: Germany
facility: Institut für Thrombophilie und Hämostaseologie
state: Nordrhein-westfalen
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
city: Blaubeuren
country: Germany
facility: Kinder- und Jugendarzt-Praxis Blaubeuren
city: Bonn
country: Germany
facility: Institute of Experimental Haematology and Transfusion Medicine
city: Brannenburg
country: Germany
facility: Praxis fur Kinder- und Jugendmedizin, Homoopathie
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
city: Delmenhorst
country: Germany
facility: Klinikum Delmehorst gGmbH, Padiatrie
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
city: Duisburg
country: Germany
facility: CRC Coagulation Research Centre GmbH
city: Halle
country: Germany
facility: Klinikum der Martin-Luther-Universitaet Halle-Wittenberg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Universitaetsklinikum Eppendorf
city: Heidelberg
country: Germany
facility: SRH Kurpfalzkrankenhaus Heidelberg
city: Koeln
country: Germany
facility: Gemeinschaftspraxis fuer Haematologie und Onkologie
city: Memmingen
country: Germany
facility: Klinikum Memmingen, Kinderklinik
city: Muenchen
country: Germany
facility: Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Kinder- und Jugendmedizin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: