UNEBI Study

JRCT ID: jRCTs051190119

Registered date:06/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: HemophiliaA with Inhibitor
• Date of first enrollment: 19/03/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Selection and administration dose of bypass hemostatic agents in rupture hemorrhage and hemostasis management during surgery

Outcome(s)

• Primary Outcome: Degree of improvement in maximum coagulation rate by coagulation waveform analysis before and after administration of fixed-dose bypass hemostatic agents

Secondary Outcome

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
2. Efficacy evaluation of emicizumab with and without addition of anti-emicizumab antibody using comprehensive coagulation tests in regular samples
3. Evaluation of hemostasis status and occurrence of TMA or TE in clinical symptoms
4. Evaluation of general coagulation and haematological tests before and after bypass hemostatic agents administration, and that in regular samples

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: Not applicable
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nogami Keiji
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd