The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
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 : 1. Patients with Hemophilia A with FVIII inhibitors 2. Patients with severe Hemophilia A without FVIII inhibitors.
Observational [Patient Registry]
Annualized Bleeding episode Rate (ABR)
Hemophilia A With Inhibitor
Emicizumab subcutaneous injection
Study Arms / Comparison 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
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 28, 2019
Primary Completion Date
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
N/A - N/A
Accepts Healthy Volunteers
Chuhl Joo Lyu, Prof, +82222282060, [email protected]
Korea, Republic of
Korea, Republic of
Chuhl Joo Lyu, Prof, Principal Investigator, Severance Hospital