HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors).
Not Applicable
Recruiting
- Conditions
- Hemophilia A
- Registration Number
- JPRN-UMIN000032515
- Lead Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
No criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The incidence of ADRs. 2. The incidence of TE and/or TMA (including the time to onset, outcome, treatment state etc.) 3. Treatment state on the occurrence of TE and/or TMA.(including bypassing agents, treatment period, dosage volume etc. of Hemlibra and bypassing agents.) 4. Treatment state on the occurrence of bleeding of Hemlibra and Bypassing agents (including agents name, treatment period, dosage volume etc.)
- Secondary Outcome Measures
Name Time Method - The time to onset of ADRs. - The treatment status and outcome of ADRs. - Occurrence state of bleeding. - Annualized Bleeding Rate (ABR).