Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A
NCT ID: NCT02610127
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2015-12-30
2019-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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OBIZUR - Prospective Participants
Participants enrolled and treated with Obizur after the prospective study start date
OBIZUR
Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.
OBIZUR - Retrospective Participants
Retrospective chart review of participants treated with OBIZUR from product approval date until prior to the prospective study start date
OBIZUR
Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.
Interventions
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OBIZUR
Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has AHA, and is being treated/was treated with Obizur.
3. Participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required
Exclusion Criteria
2. Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
3. Participant has participated in another 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 during the course of the study.
18 Years
ALL
No
Sponsors
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Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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University of Colorado Health
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Tulane University Hospital & Clinics
New Orleans, Louisiana, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Washington University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Comprehensive Cancer Center of Wake Forest Unversity
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Blood Center of Southeast Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS36659
Identifier Type: REGISTRY
Identifier Source: secondary_id
241302
Identifier Type: -
Identifier Source: org_study_id
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