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Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

IDENTIFIERS
Trial Protocol: 241501
Clinicaltrials.gov: NCT03199794
EUPAS: EUPAS16055
PURPOSE

The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

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Trial at a glance

What medical condition is being studied?   Acquired Hemophilia A
What is the trial testing?   OBIZUR
How many participants are being enrolled?   50
When is the trial being conducted?    - 
How long is participation in the trial?   A participant with acquired hemophilia (AH) must be prescribed Obizur for the treatment of a bleeding episode by a physician, independent of and prior to the decision to enrol the participant in the study.

Key requirements

Sex   
All
Age   
From 18 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   N/A
Trial Type:   Observational
Trial Arms/Groups or Cohorts:   
OBIZUR participants: Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
Intervention:   OBIZUR
Primary Outcome Measure(s):   
Number of AEs and SAEs including seriousness, severity and outcome [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Number of thromboembolic events [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Number of dose dispensing medication errors [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Secondary Outcome Measure(s):   
Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Obizur treatment regimen, as available [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Other medication administered for haemostatic control, as available [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Overall effectiveness assessment for resolution of bleeding [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Dose per infusion administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Number of infusions administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Time to achieve bleeding control, death or change in haemostatic treatment other than Obizur [Time Frame: From first administration of Obizur up to 180 days after the last administration of Obizur.]
Entry Criteria:
Inclusion Criteria: - Adult participant (or legal representative) is willing to provide informed consent - Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice Exclusion Criteria: - Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections - 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

Trial Locations

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RESULTS
University of Florida - Shands

1515 SW Archer Rd, Gainesville, FL 32608, USA

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Henry Ford Hospital

2799 W Grand Blvd, Detroit, MI 48202, USA

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Duke University Medical Center

10 Duke Medicine Cir, Durham, NC 27710, USA

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Cleveland Clinic

Cleveland, OH 44103, USA

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University Hospitals Cleveland Medical Center

11100 Euclid Ave, Cleveland, OH 44106, USA

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The University of Texas Health Science Center at Houston

7000 Fannin St #1200, Houston, TX 77030, USA

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AKH - Medizinische Universität Wien

Spitalgasse 23, 1090 Wien, Austria

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CHU de Rouen - Hôpital Charles Nicolle

37 Boulevard Gambetta, 76000 Rouen, France

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Vivantes Klinikum im Friedrichshain

Landsberger Allee 49, 10249 Berlin, Germany

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Universitaetsklinikum Bonn

Venusberg-Campus 1, 53127 Bonn, Germany

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Universitaetsklinikum Carl Gustav Carus TU Dresden

Fetscherstraße 74, 01307 Dresden, Germany

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Klinikum der Johann Wolfgang Goethe-Universitaet

Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany

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Medizinische Hochschule Hannover

Carl-Neuberg-Straße 1, 30625 Hannover, Germany

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Azienda Ospedaliera Pugliese Ciaccio

Viale Papa Pio X, 83, 88100 Catanzaro CZ, Italy

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Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Via del Vespro, 129, 90127 Palermo PA, Italy

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Fondazione IRCCS Policlinico San Matteo

Viale Camillo Golgi, 19, 27100 Pavia PV, Italy

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Policlinico Universitario Agostino Gemelli

Via della Pineta Sacchetti, 217, 00168 Roma RM, Italy

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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

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Istituto Clinico Humanitas

Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy

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Radboud University Medical Centre

Geert Grooteplein Zuid 10, 6525 GA Nijmegen, Netherlands

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University Hospital Birmingham

Mindelsohn Way, Birmingham B15 2TH, UK

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St James's University Hospital

Beckett St, Harehills, Leeds LS9 7TF, UK

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Royal Free Hospital

Pond St, Hampstead, London NW3 2QG, UK

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Churchill Hospital

Old Rd, Headington, Oxford OX3 7LE, UK

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Southampton General Hospital

Coxford Rd, Southampton SO16 5YA, UK

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Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

Via Venezia, 16, 15121 Alessandria AL, Italy

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Trial Protocol ID: 241501
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