Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2011-03-15
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fabry's Disease under Replagal
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age\> 4 years
* Patient is under Replagal since at least 12 weeks ® therapy
* The patient is compliant, the previous Replagal ® infusions were performed approximately every 2 weeks in the center close to home or at the hospital / general practitioner at
* Patient has been well tolerated Replagal ® therapy, and there were in the last 12 weeks before inclusion in this study no significant infusion reactions to
* The patient has been selected before inclusion in this study for a home infusion therapy and has consented to (or their legal representative)
* The patient / be lawful. Representative has consented in writing to participate in this study.
Exclusion Criteria
* Patient/legal representative declines Replagal® home therapy
* The patient is participating in a clinical trial with a medicinal product
4 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Landeskrankenhaus Bregenz
Bregenz, , Austria
LKH-Universitätsklinikum Graz
Graz, , Austria
Paracelsus Medizinische Privatuniversität Salzburg
Salzburg, , Austria
Universitätsklinik für Innere Medizin III
Vienna, , Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, , Austria
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Klinik II für Innere Medizin
Cologne, , Germany
Med. Versorgungszentrum Dialyse-Centrum Cuxhaven
Cuxhaven, , Germany
Alfried-Krupp-Krankenhaus Rüttenscheid
Essen, , Germany
MVZ Immunologie am Krankenhaus Sachsenhausen
Frankfurt, , Germany
Zentrum für Kinder und Jugendmedizin
Freiburg im Breisgau, , Germany
Universitätsklinikum Gießen und Marburg
Giessen, , Germany
Facharzt für Allgemeinmedizin
Hagen, , Germany
Facharzt für Innere Medizin/Kardiologie
Höxter, , Germany
Hans-Berger-Klinik für Neurologie
Jena, , Germany
Universitätsklinikum Mainz, Zentrum für Kinder- und Jugendmedizin
Mainz, , Germany
Private Practice, Dr. Glenn Sommer
Marienberg, , Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
München, , Germany
Klinikum rechts der Isar
München, , Germany
Landesklinikum St. Pölten, Neurologie
Pölten, , Germany
Nephrologisches Zentrum Rendsburg
Rendsburg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Countries
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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Shire/CS02
Identifier Type: -
Identifier Source: org_study_id
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