Phase III clinical trial of emicizumab in hemophilia A patients without inhibitors

A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITHOUT INHIBITORS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223290

Enrollment

152

Registered

2016-08-10

Start date

2016-10-18

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 without inhibitors

Interventions

investigational material(s) Generic name etc : emicizumab (ACE910, RO5534262) INN of investigational material : emicizumab Therapeutic category code : 634 Human blood preparations Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 12 years or older at the time of informed consent 2) Body weight >= 40 kg at the time of screening 3) Diagnosis of severe congenital hemophilia A (intrinsic FVIII level = 0.6 BU) in the last 5 years

Exclusion criteria

Exclusion criteria: 1) Inherited or acquired bleeding disorder other than hemophilia A 2) Previous or current treatment for thromboembolic disease or signs of thromboembolic diseaseOngoing (or plan to receive during the study) immune tolerance induction therapy or prophylaxis with FVIII 3) Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis 4) History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Observation	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Observation, Laboratory tests	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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