EBI Study
Not Applicable
- Conditions
- HemophiliaA with Inhibitor
- Registration Number
- JPRN-jRCTs051190119
- Lead Sponsor
- ogami Keiji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
1. Congenital Hemophilia A with inhibitors over 4 years old
2. Patients treated or planned for emicizumab base on the latest package insert
3. Patients with written consent has been obtained, explaining the content of this clinical study
4. Patients who can comply with the planned procedure in this clinical study
Exclusion Criteria
1. Patients who have difficulty in regular visits and/or visits at the event
2. Patients with other diseases with abnormal liver function or platelets
3. Patients who have difficulty collecting blood
4. Judged by the investigator to be inappropriate for some reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of improvement in maximum coagulation rate by coagulation waveform analysis before and after administration of fixed-dose bypass hemostatic agents
- Secondary Outcome Measures
Name Time Method 1. Comparative evaluation with and without addition of anti-emicizumab antibody for changes of comprehensive coagulation parameter before and after administration of bypass hemostatic agents<br>2. Efficacy evaluation of emicizumab with and without addition of anti-emicizumab antibody using comprehensive coagulation tests in regular samples<br>3. Evaluation of hemostasis status and occurrence of TMA or TE in clinical symptoms<br>4. Evaluation of general coagulation and haematological tests before and after bypass hemostatic agents administration, and that in regular samples