Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A

Completed

Conditions studied: Acquired Hemophilia A

In brief

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.

Key facts

Study ID

NCT02610127

Run by

Baxalta now part of Shire

People needed

53

Starts

2015-12-30

Expected to finish

2019-06-07

Last updated by the study team

2021-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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