Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A
- Conditions
- Acquired Hemophilia A
- Interventions
- Biological: OBIZUR
- Registration Number
- NCT02610127
- Lead Sponsor
- Baxalta now part of Shire
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- Participant is ≥18 years of age at the time of informed consent.
- Participant has AHA, and is being treated/was treated with Obizur.
- Participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required
- Participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein.
- Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OBIZUR - Prospective Participants OBIZUR Participants enrolled and treated with Obizur after the prospective study start date OBIZUR - Retrospective Participants OBIZUR Retrospective chart review of participants treated with OBIZUR from product approval date until prior to the prospective study start date
- Primary Outcome Measures
Name Time Method Incidence of therapy-related SAEs and level of severity Throughout the study period of approximately 4 years
- Secondary Outcome Measures
Name Time Method Occurrence of any thrombogenic event Throughout the study period of 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 Occurrence of hypersensitivity reactions Throughout the study period of approximately 4 years Time to bleeding resolution, participant study termination, or switch to another treatment 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 Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations. Throughout the study period of approximately 4 years Hemostatic effectiveness assessment for resolution of bleeding Throughout the study period, up to approximately 4 years Determined as either bleeding stopped or did not stop
Number of Obizur infusions required for control of bleeding Throughout the study period, up to approximately 4 years
Trial Locations
- Locations (16)
University of Florida
🇺🇸Gainesville, Florida, United States
University of Colorado Health
🇺🇸Aurora, Colorado, 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
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Tulane University Hospital & Clinics
🇺🇸New Orleans, Louisiana, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Comprehensive Cancer Center of Wake Forest Unversity
🇺🇸Winston-Salem, North Carolina, 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