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Clinical Trials/JPRN-jRCT2080223243
JPRN-jRCT2080223243CompletedPhase 3

A MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS WITH INHIBITORS

CHUGAI PHARMACEUTICAL CO., LTD.0 sites88 target enrollmentStarted: June 14, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
88
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Emicizumab prophylaxis achieved substantial efficacy and was well tolerated in children with hemophilia A with FVIII inhibitors.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
ot applicable to <= 17age old (—)
Sex
All

Inclusion Criteria

  • •1) Aged younger than 12 years old or 12~17 years old who weigh < 40 kg at the time of informed consent
  • •2) Body weight > 3 kg at the time of informed consent
  • •3) Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (i.e.,>= 5 Bethesda Units)
  • •4) Requires treatment with bypassing agents

Exclusion Criteria

  • •1) Inherited or acquired bleeding disorder other than hemophilia A
  • •2) Ongoing (or plan to receive during the study) immune tolerance induction therapy(ITI) or prophylaxis with FVIII. Patients awaiting initiation of ITI will be eligible. Patients in whom ITI has failed will be eligible with a 72-hour washout period prior to the
  • •first emicizumab administration.
  • •3) Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or signs of thromboembolic disease

Investigators

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