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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:December 30, 2015
End Date:August 1, 2019
Contact:Oliver Mauric, MSc
Email:oliver.mauric@shire.com
Phone:+43 1 20100 247 6826

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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.

Inclusion Criteria:

1. Participant is ≥18 years of age at the time of informed consent.

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:

1. Participant has a known anaphylactic reaction to the active substance, to any of the
excipients, or to hamster protein.

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.
We found this trial at
16
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East Lansing, Michigan 48824
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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12605 East 16th Avenue
Aurora, Colorado 80045
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Detroit, Michigan 48202
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Indianapolis, Indiana 46260
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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638 North 18th Street
Milwaukee, Wisconsin 53225
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New Orleans, Louisiana 70112
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Philadelphia, Pennsylvania 19104
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
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