Brief Title
The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Official Title
Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Brief Summary
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
Target subject : 1. Patients with Hemophilia A with FVIII inhibitors 2. Patients with severe Hemophilia A without FVIII inhibitors.
Study Type
Observational [Patient Registry]
Primary Outcome
Adverse events
Secondary Outcome
Annualized Bleeding episode Rate (ABR)
Condition
Hemophilia A With Inhibitor
Intervention
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
17
Start Date
August 28, 2019
Completion Date
February 2025
Primary Completion Date
July 2024
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Chuhl Joo Lyu, Prof, +82222282060, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04805801
Organization ID
JWP-HEM-401
Responsible Party
Sponsor
Study Sponsor
JW Pharmaceutical
Study Sponsor
Chuhl Joo Lyu, Prof, Principal Investigator, Severance Hospital
Verification Date
July 2021