Status:
COMPLETED
A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH Patients
Lead Sponsor:
Handok Inc.
Conditions:
PNH
Eligibility:
All Genders
18+ years
Brief Summary
This study is a retrospective non-interventional study, and the main objective of this study is to identify the impact of eculizumab treatment and the improvement of complications before and after ecu...
Eligibility Criteria
Inclusion
- Patients with PNH aged 18 years or older who started eculizumab treatment in accordance with drug label between 2012 and January 31st, 2020. (However, patients who have received eculizumab as part of a clinical trial or an expanded access program/compassionate use program prior to 2012 are also eligible.)
- Patients who are vaccinated against Neisseria meningitidis at least 2 weeks prior to starting eculizumab treatment. Patients who have been treated with appropriate prophylactic antibiotic therapy for 2 weeks after vaccination if they received eculizumab within 2 weeks after the vaccination.
Exclusion
- Pediatric patients with PNH aged under 18 years
- Patients with hypersensitivity to the active ingredients of eculizumab, murine protein, or other components
- Patients with untreated severe meningococcal (Neisseria meningitidis) infection
- Patients who received other complement inhibitors for PNH before or during eculizumab treatment
Key Trial Info
Start Date :
December 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 3 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05337683
Start Date
December 11 2020
End Date
January 3 2022
Last Update
January 28 2025
Active Locations (1)
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1
Handok
Seoul, South Korea