Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

Study Overview
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Brief Summary
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The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

Official Title
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Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

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: Adult participant (or legal representative) is willing to provide informed consent Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice Exclusion Criteria: Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections Participant has participated in a 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 at study entry

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 participants<br>Participants previously treated with OBIZUR and continue to be treated with OBIZUR during the study. | Biological: OBIZUR<br>* Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.<br>* Other names: Antihemophilic Factor (Recombinant);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of AEs and SAEs including seriousness, severity and outcome | AE - adverse event, SAE - serious adverse event. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Number of AESIs including seriousness, severity, relationship to therapy, outcome, and treatment discontinuation | Adverse Events of Special Interest (AESI) are as follows: hypersensitivity reactions, thromboembolic events and dose dispensing medication errors. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Number of thromboembolic events | Thromboembolic events include disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Number of dose dispensing medication errors | Dose dispensing medication erros include miscalculation of dose while prescribing (calculation of correct dose based on the participant's weight) or administration of the incorrect dose. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity; newly recognized anti-pFVIII inhibitor or increase in titre of anti-pFVIII inhibitors and evolution of titre over time |  | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Obizur treatment regimen, as available | This may include details of the Obizur treatment regimen utilized, as available | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Other medication administered for haemostatic control, as available | This may include additional medications, treatments and procedures (other than Obizur) undertaken to control a bleeding episode. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Overall effectiveness assessment for resolution of bleeding | Resolution of bleeding determined as either bleeding stopped or did not stop. If bleeding did not stop, a reason should be provided. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Dose per infusion administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur | Bleeding control defined as all bleeding stopped. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Number of infusions administered to achieve bleeding control, death or change in haemostatic treatment other than Obizur | Bleeding control defined as all bleeding stopped. | From first administration of Obizur up to 180 days after the last administration of Obizur. | 
| Time to achieve bleeding control, death or change in haemostatic treatment other than Obizur | Bleeding control defined as all bleeding stopped. | From first administration of Obizur up to 180 days after the last administration of Obizur. |