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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 8, 2008
Last updated: November 22, 2016
Last verified: November 2016
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.

Condition Intervention
Hemophilia B
Drug: BeneFIX

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reporting of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy in controlling bleeding [ Time Frame: 36 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Hemophilia B
Drug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia B

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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00714415

Contact: Pfizer Call Center 1-800-718-1021

Allgemeines Krankenhaus Linz, Kinderklinik Recruiting
Linz, Austria, 4020
Sonnengesundheitszentrum Recruiting
München, Bayern, Germany, 80336
Werlhof-Institut für Haemostaseologie GmbH Recruiting
Hannover, Niedersachsen, Germany, 30159
Institut für Thrombophilie und Hämostaseologie Recruiting
Muenster, Nordrhein-westfalen, Germany, 48143
Vivantes Klinikum im Friedrichshain Recruiting
Berlin, Germany, 10249
Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie Recruiting
Berlin, Germany, 13353
Kinder- und Jugendarzt-Praxis Blaubeuren Recruiting
Blaubeuren, Germany, 89143
Institute of Experimental Haematology and Transfusion Medicine Recruiting
Bonn, Germany, 53127
Praxis fur Kinder- und Jugendmedizin, Homoopathie Recruiting
Brannenburg, Germany, 83098
Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik Active, not recruiting
Bremen, Germany, 28177
Klinikum Delmehorst gGmbH, Padiatrie Recruiting
Delmenhorst, Germany, 27753
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie Recruiting
Duesseldorf, Germany, 40225
CRC Coagulation Research Centre GmbH Recruiting
Duisburg, Germany, 47051
Klinikum der Martin-Luther-Universitaet Halle-Wittenberg Recruiting
Halle, Germany, 06120
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Eppendorf Recruiting
Hamburg, Germany, 20251
SRH Kurpfalzkrankenhaus Heidelberg Recruiting
Heidelberg, Germany, 69123
Gemeinschaftspraxis fuer Haematologie und Onkologie Recruiting
Koeln, Germany, 50677
Klinikum Memmingen, Kinderklinik Recruiting
Memmingen, Germany, 87700
Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen Recruiting
Muenchen, Germany, 80337
Universitaetsklinik fuer Kinder- und Jugendmedizin Recruiting
Tuebingen, Germany, 72076
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00714415     History of Changes
Other Study ID Numbers: 3090A1-4406  B1821011 
Study First Received: July 8, 2008
Last Updated: November 22, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked processed this record on December 09, 2016