Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice
2 other identifiers
observational
50
7 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2016
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2016
CompletedFirst Submitted
Initial submission to the registry
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedJuly 21, 2022
July 1, 2022
4.6 years
June 23, 2017
July 18, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Number of AEs and SAEs including seriousness, severity and outcome
AE - adverse event, SAE - serious adverse event.
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.
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.
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.
From first administration of Obizur up to 180 days after the last administration of Obizur.
Secondary Outcomes (7)
Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time
From first administration of Obizur up to 180 days after the last administration of Obizur.
Obizur treatment regimen, as available
From first administration of Obizur up to 180 days after the last administration of Obizur.
Other medication administered for haemostatic control, as available
From first administration of Obizur up to 180 days after the last administration of Obizur.
Overall effectiveness assessment for resolution of bleeding
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
From first administration of Obizur up to 180 days after the last administration of Obizur.
- +2 more secondary outcomes
Study Arms (1)
OBIZUR participants
Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study.
Interventions
Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Florida - Shands
Gainesville, Florida, 32608, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76000, France
Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01304, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15100, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, 88100, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Rome, 00161, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Radboud University Medical Centre
Nijmegen, 6525 GA, Netherlands
University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Southampton General Hospital
Southampton, SO16 5YA, United Kingdom
Related Publications (1)
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.
PMID: 39228858DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2017
First Posted
June 27, 2017
Study Start
December 14, 2016
Primary Completion
July 30, 2021
Study Completion
July 30, 2021
Last Updated
July 21, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.