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Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: BeneFIX (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

Official title: Benefix Pharmacovigilance Evaluation

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Reporting of adverse events

Secondary outcome: Efficacy in controlling bleeding

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

Eligibility

Minimum age: 999 Days. Maximum age: N/A. Gender(s): Both.

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®.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Allgemeines Krankenhaus Linz, Kinderklinik, Linz 4020, Austria; Recruiting

Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie, Berlin 13353, Germany; Recruiting

Vivantes Klinikum im Friedrichshain, Berlin 10249, Germany; Recruiting

Kinder- und Jugendarzt-Praxis Blaubeuren, Blaubeuren 89143, Germany; Recruiting

Institute of Experimental Haematology and Transfusion Medicine, Bonn 53127, Germany; Recruiting

Praxis fur Kinder- und Jugendmedizin, Homoopathie, Brannenburg 83098, Germany; Recruiting

Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik, Bremen 28177, Germany; Recruiting

Klinikum Delmehorst gGmbH, Padiatrie, Delmenhorst 27753, Germany; Recruiting

Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie, Duesseldorf 40225, Germany; Recruiting

CRC Coagulation Research Centre GmbH, Duisburg 47051, Germany; Recruiting

Klinikum der Martin-Luther-Universitaet Halle-Wittenberg, Halle 06120, Germany; Recruiting

Universitaetsklinikum Eppendorf, Hamburg 20251, Germany; Recruiting

Universitaetsklinikum Hamburg-Eppendorf, Hamburg 20246, Germany; Recruiting

SRH Kurpfalzkrankenhaus Heidelberg, Heidelberg 69123, Germany; Recruiting

Gemeinschaftspraxis fuer Haematologie und Onkologie, Koeln 50677, Germany; Recruiting

Klinikum Memmingen, Kinderklinik, Memmingen 87700, Germany; Recruiting

Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen, Muenchen 80337, Germany; Recruiting

Universitaetsklinik fuer Kinder- und Jugendmedizin, Tuebingen 72076, Germany; Recruiting

Sonnengesundheitszentrum, München, Bayern 80336, Germany; Recruiting

Werlhof-Institut für Haemostaseologie GmbH, Hannover, Niedersachsen 30159, Germany; Recruiting

Institut für Thrombophilie und Hämostaseologie, Muenster, Nordrhein-Westfalen 48143, Germany; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2008
Last updated: August 4, 2015

Page last updated: August 20, 2015

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