A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH Patients

NCT ID: NCT05337683

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-11

Study Completion Date

2022-01-03

Brief Summary

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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 eculizumab treatment, and to evaluate the safety during the treatment and the clinical unmet needs during the treatment in PNH patients in real-world.

Detailed Description

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Conditions

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PNH

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Handok

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HD_ECU_OS2020

Identifier Type: -

Identifier Source: org_study_id

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