The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

Study Overview
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Brief Summary
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To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.

Detailed Description
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Target subject : Patients with Hemophilia A with FVIII inhibitors Patients with severe Hemophilia A without FVIII inhibitors.

Official Title
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Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

Conditions
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Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor

Intervention / Treatment
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* Drug: Emicizumab subcutaneous injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator Signed informed consent form Exclusion Criteria: Subjects who are hypersensitive to Emicizumab Subjects who are hypersensitive to mouse or hamster protein Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug Subjects who participated in other clinical trials within a month before enrollment (or the first administration of Hemlibra SC inj.) (Unable to participate in other clinical trials related to Hemophilia A treatment even after enrollment) Subjects who the investigator deems inappropriate for the study. Moderate/Mild for Hemophilia A patients without FVIII inhibitors
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 |
| --- | --- |
| Hemophilia A with FVIII inhibitors<br>Hemophilia A patients with FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W | Drug: Emicizumab subcutaneous injection<br>* Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.<br>* Other names: Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test;|
| Hemophilia A without FVIII inhibitors<br>Hemophilia A patients without FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W | Drug: Emicizumab subcutaneous injection<br>* Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.<br>* Other names: Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | AEs will be described for AEs and Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), other important AEs. Severity, outcome, causal relationship with study drug, etc. of AEs will be analyzed. | for 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Bleeding episode Rate (ABR) | The number of bleeds will be also annualized for each patient using the following formula | for 24weeks |