CAGUYAMA Study

JRCT ID: jRCTs051210137

Registered date:20/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hemophilia A without inhibitor
• Date of first enrollment: 17/01/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Selection and dosage of factor VIII formulations in rupture hemorrhage or hemostasis management during surgery

Outcome(s)

• Primary Outcome: Maximum coagulation velocity by modified clot waveform analysis after administration of FVIII product

Secondary Outcome

1)Evaluation of hemostasis status in clinical symptoms
2)Coagulation parameters before and after administration of FVIII product with and without addition of anti-emicizumab antibody
3)Coagulation parameters at the time of registration and before administration of FVIII product with or without addition of anti-emicizumab antibody
4)General coagulation parameters and blood level of emicizumab in blood samples before and after administration of FVIII product
5)General coagulation parameters and blood level of emicizumab in blood samples at the time of registration and before administration of FVIII product

Key inclusion & exclusion criteria

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

Include criteria

1)Congenital hemophilia A patients without inhibitor over 4 years old
2)Patients receiving emicizumab 5 times or more based on the latest package insert
3)Patients who have received sufficient explanation about the contents of this clinical study, and have obtained written consent from the study patients or their legal guardian
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 events
2)Patients with other diseases with abnormal liver function or platelet count (AST and/or ALT are 5 times or more of the normal upper limit. Platelet count<100,000/microliter)
3)Patients with extremely difficult blood collection
4)Patients who are 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