Phase III clinical trial of emicizumab in hemophilia A patients without inhibitors
- Conditions
- Hemophilia A without inhibitors
- Registration Number
- JPRN-jRCT2080223290
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
The administration of emicizumab once weekly or every 2 weeks was associated with significantly lower bleeding rates than the rate with no prophylaxis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 152
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 <1%)
4) No documented inhibitor (>= 0.6 BU) in the last 5 years
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method