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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS16055 | Registry Identifier | ENCePP |
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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBIZUR participants | Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OBIZUR | Biological | Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida - Shands | Gainesville | Florida | 32608 | United States | ||
| Henry Ford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39228858 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
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This may include details of the Obizur treatment regimen utilized, 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 | This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode. | 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. | 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. | 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. | 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. | From first administration of Obizur up to 180 days after the last administration of Obizur. |
| 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 |
| ID | Term |
|---|---|
| C536392 | Factor 8 deficiency, acquired |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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