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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 Participants who meet ALL of the following criteria are eligible for this study: •Adult participant or legal authorised representative is willing to provide informed consent, unless informed consent is not required (e.g. participants who are deceased), as local regulations allow. •Participant is being treated or was treated with Obizur in routine clinical practice Exclusion Criteria Participants who meet ANY of the following criteria are not eligible for this study: •Participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrolment or is scheduled to participate in a clinical study involving a medicinal product or device at study entry •Participant has known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients of Obizur listed in the summary of product characteristics/package leaflet (SPC /PL) -> The following list of excipients can be found in the SPC/PL: •Powder: 1.Polysorbate 80 2.Sodium chloride 3.Calcium chloride dihydrate 4.Sucrose 5.Tris Base 6.Tris HCl 7.Tri-sodium citrate dihydrate •Solvent: 1.Sterilised water for injections •US Participant who has participated in the post-marketing study, NCT2610127

Trial Locations

Any
Recruiting
Completed
Any
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

Completed
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Trial Protocol ID: 241501
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