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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-28

Study Completion Date

2025-02-28

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.

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Detailed Description

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Target subject :

1. Patients with Hemophilia A with FVIII inhibitors
2. Patients with severe Hemophilia A without FVIII inhibitors.

Conditions

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Hemophilia A With Inhibitor Hemophilia A Without Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Emicizumab subcutaneous injection

Intervention Type DRUG

Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

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

Emicizumab subcutaneous injection

Intervention Type DRUG

Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

Interventions

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Emicizumab subcutaneous injection

Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

Intervention Type DRUG

Other Intervention Names

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Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test

Eligibility Criteria

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Inclusion Criteria

1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator
2. Signed informed consent form

Exclusion Criteria

1. Subjects who are hypersensitive to Emicizumab
2. Subjects who are hypersensitive to mouse or hamster protein
3. Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug
4. 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)
5. Subjects who the investigator deems inappropriate for the study.
6. Moderate/Mild for Hemophilia A patients without FVIII inhibitors

Eligible Sex

ALL

Accepts Healthy Volunteers

No