Special Drug Use-Results Survey (All-Case Surveillance) to Investigate Safety and Effectiveness in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Empaveli in the Post-Marketing Clinical Use in Japa
Not Applicable
Recruiting
- Conditions
- Paroxysmal nocturnal hemoglobinuria
- Registration Number
- JPRN-jRCT2031230275
- Lead Sponsor
- Shimmoto Naoki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
All patients with PNH who received Empaveli in Japan from the date of product launch to 31 May 2028 or until the approval conditions are lifted.
Exclusion Criteria
Not applicable.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of the following adverse reactions:<br>Hypersensitivity, Meningococcal infection, Infections (except meningococci), Serious hemolysis due to discontinuation of Empaveli.
- Secondary Outcome Measures
Name Time Method