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HINODE study

Phase 4
Recruiting
Conditions
Congenital haemophilia A
Registration Number
JPRN-jRCT1031230264
Lead Sponsor
ogami Keiji
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

Inclusion criteria;
1)Patientss for whom consent to participate in the study has been obtained from proxy consenters by means of written informed consent
2) Confirmed diagnosis with Congenital haemophilia A at enrollment.
3)Patients selected for the treatment with emicizumab as the most appropriate medical treatment (those who planned to receive emicizumab treatment in the selection of the treatment between physicians and patients) and who are receiving or scheduled to receive emicizumab according to the current electronic package insert dosage and administration.
4)Patients who have reached or are likely to reach the maintenance phase* of emicizumab at less than 12 months of age and are able to obtain blood samples in the maintenance phase* of less than 12 months of age.
*The maintenance phase in this study refers to the fifth and subsequent doses of emicizumab.

Exclusion Criteria

Exclusion criteria;
1)Patients with inherited or acquired bleeding disorders other than haemophilia A.
2)Patients to be inappropriate to enter this study for some other reason judged by the investigators.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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