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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00714415
First received: July 8, 2008
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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 Phase
Hemophilia B
Drug: BeneFIX
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefix Pharmacovigilance Evaluation

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: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A.
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

  Eligibility

Ages Eligible for Study:   999 Days and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hemophilia B

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®.
  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 ClinicalTrials.gov identifier: NCT00714415

Locations
Austria
Allgemeines Krankenhaus Linz, Kinderklinik
Linz, Austria, 4020
Germany
Werlhof-Institut für Haemostaseologie GmbH
Hannover, Niedersachsen, Germany, 30159
Institut für Thrombophilie und Hämostaseologie
Muenster, Nordrhein-Westfalen, Germany, 48143
Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie
Berlin, Germany, 13353
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00714415     History of Changes
Other Study ID Numbers: 3090A1-4406, B1821011
Study First Received: July 8, 2008
Last Updated: October 30, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on November 27, 2014