Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A
2 other identifiers
observational
53
1 country
16
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.
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 2015
Typical duration for all trials
16 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
First Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedAugust 5, 2021
August 1, 2021
3.4 years
October 29, 2015
August 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of therapy-related SAEs and level of severity
Throughout the study period of approximately 4 years
Secondary Outcomes (8)
Hemostatic effectiveness assessment for resolution of bleeding
Throughout the study period, up to 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
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
- +3 more secondary outcomes
Study Arms (2)
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
Interventions
Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Colorado Health
Aurora, Colorado, 80045, United States
University of Florida
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
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
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
November 20, 2015
Study Start
December 30, 2015
Primary Completion
June 7, 2019
Study Completion
June 7, 2019
Last Updated
August 5, 2021
Record last verified: 2021-08
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.