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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS36659 | Registry Identifier | EUPAS |
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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
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The overall objective is to enroll patients with acquired hemophilia A (AHA) who are prescribed and treated with Obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.
This study is a multi-center, uncontrolled, open-label, non-interventional post-marketing safety surveillance study to describe the use of Obizur in patients with acquired hemophilia A (AHA), and secondarily, where data are available, to describe the hemostatic effectiveness and immunogenicity of Obizur.
Patients should be enrolled at the earliest possible time point after initiating Obizur.
In an attempt to collect safety and utilization data on patients treated with Obizur since Food and Drug Administration (FDA) approval in October 2014, Baxalta will make an effort to identify all persons treated with Obizur and to collect data for as many patients as possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBIZUR - Prospective Participants | Participants enrolled and treated with Obizur after the prospective study start date |
| |
| OBIZUR - Retrospective Participants | Retrospective chart review of participants treated with OBIZUR from product approval date until prior to the prospective study start date |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OBIZUR | Biological | Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of therapy-related SAEs and level of severity | Throughout the study period of approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic effectiveness assessment for resolution of bleeding | Determined as either bleeding stopped or did not stop | Throughout the study period, up to approximately 4 years |
| Time to bleeding resolution, participant study termination, or switch to another treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health | Aurora | Colorado | 80045 | United States | ||
| University of Florida |
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| 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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| Throughout the study period, up to approximately 4 years |
| Number of Obizur units/kg required for control of bleeding | Throughout the study period, up to approximately 4 years |
| Number of Obizur infusions required for control of bleeding | Throughout the study period, up to approximately 4 years |
| Titer of newly recognized anti-porcine Factor VIII (anti-pFVIII) neutralizing antibodies (inhibitors) or increase in titer of anti-pFVIII inhibitors from baseline and changes over time. | Throughout the study period of approximately 4 years |
| Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations. | Throughout the study period of approximately 4 years |
| Occurrence of hypersensitivity reactions | Throughout the study period of approximately 4 years |
| Occurrence of any thrombogenic event | Throughout the study period of approximately 4 years |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61615 | United States |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| Tulane University Hospital & Clinics | New Orleans | Louisiana | 70112 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Comprehensive Cancer Center of Wake Forest Unversity | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Blood Center of Southeast Wisconsin | Milwaukee | Wisconsin | 53225 | United States |
| 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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