Status:
UNKNOWN
The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Lead Sponsor:
JW Pharmaceutical
Conditions:
Hemophilia A With Inhibitor
Hemophilia A Without Inhibitor
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator
- Signed informed consent form
Exclusion
- Subjects who are hypersensitive to Emicizumab
- Subjects who are hypersensitive to mouse or hamster protein
- Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug
- 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)
- Subjects who the investigator deems inappropriate for the study.
- Moderate/Mild for Hemophilia A patients without FVIII inhibitors
Key Trial Info
Start Date :
August 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04805801
Start Date
August 28 2019
End Date
February 1 2025
Last Update
July 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yonsei University Severance Hospital
Seoul, South Korea