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

NCT ID: NCT00714415

Last Updated: 2018-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-10-31

Brief Summary

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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

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

Conditions

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Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients with Hemophilia B

BeneFIX

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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®.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Allgemeines Krankenhaus Linz, Kinderklinik

Linz, , Austria

Site Status

Sonnengesundheitszentrum

München, Bavaria, Germany

Site Status

Werlhof-Institut für Haemostaseologie GmbH

Hanover, Lower Saxony, Germany

Site Status

Institut für Thrombophilie und Hämostaseologie

Münster, North Rhine-Westphalia, Germany

Site Status

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status

Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie

Berlin, , Germany

Site Status

Kinder- und Jugendarzt-Praxis Blaubeuren

Blaubeuren Abbey, , Germany

Site Status

Institute of Experimental Haematology and Transfusion Medicine

Bonn, , Germany

Site Status

Praxis fur Kinder- und Jugendmedizin, Homoopathie

Brannenburg, , Germany

Site Status

Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik

Bremen, , Germany

Site Status

Gemeinschaftspraxis fuer Haematologie und Onkologie

Cologne, , Germany

Site Status

Klinikum Delmehorst gGmbH, Padiatrie

Delmenhorst, , Germany

Site Status

CRC Coagulation Research Centre GmbH

Duisburg, , Germany

Site Status

Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie

Düsseldorf, , Germany

Site Status

Klinikum der Martin-Luther-Universitaet Halle-Wittenberg

Halle, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Universitaetsklinikum Eppendorf

Hamburg, , Germany

Site Status

SRH Kurpfalzkrankenhaus Heidelberg

Heidelberg, , Germany

Site Status

Klinikum Memmingen, Kinderklinik

Memmingen, , Germany

Site Status

Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen

München, , Germany

Site Status

Universitaetsklinik fuer Kinder- und Jugendmedizin

Tübingen, , Germany

Site Status

Countries

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Austria Germany

Related Links

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Other Identifiers

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B1821011

Identifier Type: OTHER

Identifier Source: secondary_id

3090A1-4406

Identifier Type: -

Identifier Source: org_study_id

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