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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.
Target subject :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia A with FVIII inhibitors | 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 |
| |
| Hemophilia A without FVIII inhibitors | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emicizumab subcutaneous injection | Drug | Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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1 .Hemophilia A patients with FVIII inhibitors 2. Severe Hemophilia A patients without FVIII inhibitors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuhl Joo Lyu, Prof | Contact | +82222282060 | CJ@yuhs.ac | |
| YoungShil Park, Prof. | Contact | +8224407174 | pysmd@khnmc.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Chuhl Joo Lyu, Prof | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Recruiting | Seoul | South Korea |
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Emicizumab Concentration Factor FVIII Inhibitor FVIII Activity
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