Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice
NCT ID: NCT03199794
Last Updated: 2022-07-21
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
50 participants
OBSERVATIONAL
2016-12-14
2021-07-30
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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OBIZUR participants
Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
OBIZUR
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
Interventions
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OBIZUR
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice
Exclusion Criteria
* Participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device at study entry
18 Years
ALL
No
Sponsors
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Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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University of Florida - Shands
Gainesville, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
AKH - Medizinische Universität Wien
Vienna, , Austria
CHU de Rouen - Hôpital Charles Nicolle
Rouen, , France
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Radboud University Medical Centre
Nijmegen, , Netherlands
University Hospital Birmingham
Birmingham, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Miesbach W, Curry N, Knobl P, Percy C, Santoro R, Schmaier AH, Trautmann-Grill K, Badejo K, Chen J, Nouri M, Oberai P, Klamroth R. Real-world use of recombinant porcine sequence factor VIII in the treatment of acquired hemophilia A: EU PASS. Ther Adv Hematol. 2024 Sep 2;15:20406207241260332. doi: 10.1177/20406207241260332. eCollection 2024.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS16055
Identifier Type: REGISTRY
Identifier Source: secondary_id
241501
Identifier Type: -
Identifier Source: org_study_id
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