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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714415
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hemophilia B Drug: BeneFIX

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

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
Study Start Date : January 2008
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Reporting of adverse events [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Efficacy in controlling bleeding [ Time Frame: 36 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714415

Allgemeines Krankenhaus Linz, Kinderklinik
Linz, Austria, 4020
München, Bayern, Germany, 80336
Werlhof-Institut für Haemostaseologie GmbH
Hannover, Niedersachsen, Germany, 30159
Institut für Thrombophilie und Hämostaseologie
Muenster, Nordrhein-westfalen, Germany, 48143
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
Berlin, Germany, 13353
Kinder- und Jugendarzt-Praxis Blaubeuren
Blaubeuren, Germany, 89143
Institute of Experimental Haematology and Transfusion Medicine
Bonn, Germany, 53127
Praxis fur Kinder- und Jugendmedizin, Homoopathie
Brannenburg, Germany, 83098
Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
Bremen, Germany, 28177
Klinikum Delmehorst gGmbH, Padiatrie
Delmenhorst, Germany, 27753
Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie
Duesseldorf, Germany, 40225
CRC Coagulation Research Centre GmbH
Duisburg, Germany, 47051
Klinikum der Martin-Luther-Universitaet Halle-Wittenberg
Halle, Germany, 06120
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitaetsklinikum Eppendorf
Hamburg, Germany, 20251
SRH Kurpfalzkrankenhaus Heidelberg
Heidelberg, Germany, 69123
Gemeinschaftspraxis fuer Haematologie und Onkologie
Koeln, Germany, 50677
Klinikum Memmingen, Kinderklinik
Memmingen, Germany, 87700
Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen
Muenchen, Germany, 80337
Universitaetsklinik fuer Kinder- und Jugendmedizin
Tuebingen, Germany, 72076
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00714415     History of Changes
Other Study ID Numbers: 3090A1-4406
B1821011 ( Other Identifier: Alias Study Number )
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

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