Phase III clinical study of emicizumab given every 4 weeks (Q4W) in patients with hemophilia A
Phase 3
Completed
- Conditions
- Hemophilia A
- Registration Number
- JPRN-jRCT2080223336
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Emicizumab given once every 4 weeks showed clinically meaningful bleed control while being well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 48
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 or hemophilia A with FVIII inhibitors
Exclusion Criteria
1)Inherited or acquired bleeding disorder other than hemophilia A
2)Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
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