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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acquired Hemophilia A

Intervention / Treatment
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* Biological: OBIZUR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OBIZUR - Prospective Participants<br>Participants enrolled and treated with Obizur after the prospective study start date | Biological: OBIZUR<br>* Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.<br>* Other names: Porcine Sequence;|
| OBIZUR - Retrospective Participants<br>Retrospective chart review of participants treated with OBIZUR from product approval date until prior to the prospective study start date | Biological: OBIZUR<br>* Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.<br>* Other names: Porcine Sequence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of therapy-related SAEs and level of severity |  | Throughout the study period of approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic effectiveness assessment for resolution of bleeding | Determined as either bleeding stopped or did not stop | 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 | 
| Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations. |  | Throughout the study period of approximately 4 years | 
| Occurrence of hypersensitivity reactions |  | Throughout the study period of approximately 4 years | 
| Occurrence of any thrombogenic event |  | Throughout the study period of approximately 4 years |