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 |
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.
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.
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
sites
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
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