NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051190119

Registered date:06/03/2020

UNEBI Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHemophiliaA with Inhibitor
Date of first enrollment06/03/2020
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Selection and administration dose of bypass hemostatic agents in rupture hemorrhage and hemostasis management during surgery

Outcome(s)

Primary OutcomeDegree of improvement in maximum coagulation rate by coagulation waveform analysis before and after administration of fixed-dose bypass hemostatic agents
Secondary Outcome1. 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 maximumNot applicable
GenderMale
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Kenichi Ogiwara
Address 840 Shijo-Cho, Kashihara, Nara,Japan Nara Japan 634-8522
Telephone +81-744-22-3051
E-mail ogiwarak@naramed-u.ac.jp
Affiliation Nara Medical University Hospital
Scientific contact
Name Keiji Nogami
Address 840 Shijo-Cho, Kashihara, Nara,Japan Nara Japan 634-8522
Telephone +81-744-22-3051
E-mail roc-noga@naramed-u.ac.jp
Affiliation Nara Medical University Hospital