Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

Study Overview
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Brief Summary
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This study is to describe the safety and efficacy of Xyntha® during the usual care setting.

Detailed Description
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non probability sample

Official Title
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Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Xyntha : coagulation factor IIIV (recombinant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement). Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha. Exclusion Criteria: Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product. Patients with a known history of hypersensitivity to hamster protein. Patients participating in an interventional trial of any investigational drug or device.
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 |
| --- | --- |
| Xyntha group<br>Xyntha will be administered according to physician's discretion. | Drug: Xyntha : coagulation factor IIIV (recombinant)<br>* Xyntha will be administered according to physician's discretion.<br>* Other names: Xyntha, MOROCTOCOG ALFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants by Family History of Factor VIII Inhibitor |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants) |  | 4 years | 
| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age |  | 4 years | 
| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age |  | 4 years | 
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants) | Response categories were excellent, good, moderate, or no response. | 4 years | 
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age | Response categories were excellent, good, moderate, or no response. | 4 years | 
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age | Response categories were excellent, good, moderate, and no response. | 4 years | 
| Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy | Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy. | 4 years | 
| Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants) |  | 4 years | 
| Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age |  | 4 years | 
| Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age |  | 4 years | 
| Percentage of Participants Experiencing Hemorrhages During Prophylaxis |  | 4 years | 
| Annualized Bleeding Rates During Prophylaxis | Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)] | 4 years | 
| Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha | Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion. | 4 years | 
| Average Infusion Dose During Prophylaxis (All Participants) |  | 4 years | 
| Average Infusion Dose During Prophylaxis in Participants <18 Years of Age |  | 4 years | 
| Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age |  | 4 years | 
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants) |  | 4 years | 
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age |  | 4 years | 
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age |  | 4 years |