Post Marketing Study of emizibumab in hemophilia A pedicatric patients less than 12 years without FVIII Inhibitors(AOZORA)

A MULTICENTER, OPEN-LABEL, POST-MARKETING STUDY TO EVALUATE THE LONG-TERM SAFETY AND JOINT HEALTH WITH ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS AGED LESS THAN 12 YEARS WITHOUT FVIII INHIBITORS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080224629

Enrollment

Registered

2019-04-09

Start date

2019-05-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

investigational material(s) Generic name etc : emicizumab INN of investigational material : emicizumab Therapeutic category code : 634 Human blood preparations Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Aged 3 kg at the time of informed consent (3) Diagnosis of severe (endogenous FVIII level <1%) congenital hemophilia A (4) Negative results for FVIII inhibitors (<0.6 BU/mL) in the most recent assay within 8 weeks prior to enrollment

Exclusion criteria

Exclusion criteria: (1) Inherited or acquired bleeding disorder other than hemophilia A (2) Current receipt of immune tolerance induction (ITI) therapy (3) Previous (within the past 12 months) or current treatment for thromboembolic disease (except patients with previous catheter-associated thrombus who are not currently receiving treatment) or signs of thromboembolic disease

Design outcomes

Primary

Measure	Time frame
safety exploratory Observation, Laboratory tests	—

Secondary

Measure	Time frame
exploratory Observation	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026