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.
Study Type
OBSERVATIONAL
Enrollment
50
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
University of Florida - Shands
Number of AEs and SAEs including seriousness, severity and outcome
AE - adverse event, SAE - serious adverse event.
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
Adverse Events of Special Interest (AESI) are as follows: hypersensitivity reactions, thromboembolic events and dose dispensing medication errors.
Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.
Number of thromboembolic events
Thromboembolic events include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke.
Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.
Number of dose dispensing medication errors
Dose dispensing medication erros include miscalculation of dose while prescribing (calculation of correct dose based on the participant's weight) or administration of the incorrect dose.
Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.
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
This may include details of the Obizur treatment regimen utilized, as available
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 16 more locations
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
This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode.
Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.
Overall effectiveness assessment for resolution of bleeding
Resolution of bleeding determined as either bleeding stopped or did not stop. If bleeding did not stop, a reason should be provided.
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
Bleeding control defined as all bleeding stopped.
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
Bleeding control defined as all bleeding stopped.
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
Bleeding control defined as all bleeding stopped.
Time frame: From first administration of Obizur up to 180 days after the last administration of Obizur.