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Clinical Trials/JPRN-jRCTs051210137
JPRN-jRCTs051210137
Recruiting
未知

Assessment of coagulation potential of concomitantly used factor VIII concentrates in hemophilia A patients with emicizumab prophylaxis - CAGUYAMA Study

ogami Keiji0 sites100 target enrollmentDecember 20, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Hemophilia A without inhibitor
Sponsor
ogami Keiji
Enrollment
100
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
ogami Keiji

Eligibility Criteria

Inclusion 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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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