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

JW Pharmaceutical

Status: Enrolling

Conditions: Hemophilia A Without Inhibitor; Hemophilia A With Inhibitor

Treatments: Drug: Emicizumab subcutaneous injection

Study type: Observational

Funder types: Industry

Identifiers

NCT04805801

JWP-HEM-401

Details and patient eligibility

About

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.

Full description

Target subject :

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

Enrollment: 17 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

Hemophilia A with FVIII inhibitors

Description:

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

Treatment:

Drug: Emicizumab subcutaneous injection

Hemophilia A without FVIII inhibitors

Description:

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

Treatment:

Drug: Emicizumab subcutaneous injection