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Clinical Trials/jRCT1031230264
jRCT1031230264RecruitingNot Applicable

Hemophilia A in infancy and newborns; multi-institutional prospective observational study to assess the efficacy and safety of emicizumab

Chugai Pharmaceutical Co., Ltd0 sites50 target enrollmentStarted: August 31, 2023Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Primary Endpoint
Relationship between various parameters of comprehensive coagulation tests and plasma emicizumab levels
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
No limit to 0age 12month 0week old not (—)
Sex
All

Inclusion Criteria

  • •Inclusion criteria;
  • •Patientss for whom consent to participate in the study has been obtained from proxy consenters by means of written informed consent
  • •Confirmed diagnosis with Congenital haemophilia A at enrollment.
  • •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.
  • •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;
  • •Patients with inherited or acquired bleeding disorders other than haemophilia A.
  • •Patients to be inappropriate to enter this study for some other reason judged by the investigators.

Outcomes

Primary Outcomes

Relationship between various parameters of comprehensive coagulation tests and plasma emicizumab levels

Relationship between various parameters of comprehensive coagulation tests and plasma emicizumab levels in congenital haemophilia A aged 6 months or older and younger than 12 months.

Secondary Outcomes

  • Generalized coagulation tests
  • Relationship between various coagulability and plasma emicizumab levels
  • Various changes in coagulation ability
  • Adverse events
  • Hemorrhage requiring treatment with blood coagulation factor products

Investigators

Sponsor
Chugai Pharmaceutical Co., Ltd

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