Post Marketing Study of emizibumab in hemophilia A pedicatric patients less than 12 years without FVIII Inhibitors(AOZORA)
Phase 4
Completed
- Conditions
- Hemophilia A
- Registration Number
- JPRN-jRCT1080224629
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
(1) Aged <12 years at the time of informed consent
(2) Body weight >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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method