FACTs
Not Applicable
Completed
- Conditions
- Hemophilia A
- Registration Number
- JPRN-jRCT1080223601
- Lead Sponsor
- Sanofi K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Patients with hemophilia A with any severity and treated with rFVIIIFc
Detailed criteria are described in the protocol.
Patients less than 18 years of age with hemophilia A with any severity and treated with rFVIIIFc. (include over 18 years patients in part 2 study)
Part 1 study: general pediatric study
Part 2 study: inhibitor positive patient diagnosed by the treating physician
Exclusion Criteria
Candidates will be excluded from study entry if any of the following exclusion criteria exist.
1.Patients to whom Informed consent cannot be conducted or who have no willingness to provide informed consent
2.Those with other bleeding disorder than hemophilia A
3.Patients 18 years of age and older at entry (part 1 study)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method