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

Completed

Conditions studied: Acquired Hemophilia A

In brief

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.

Key facts

Study ID

NCT03199794

Run by

Baxalta now part of Shire

People needed

50

Starts

2016-12-14

Expected to finish

2021-07-30

Last updated by the study team

2022-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.