A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea

NCT ID: NCT05405777

Last Updated: 2025-01-27

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

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-04

Study Completion Date

2022-12-31

Brief Summary

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Primary objective

\- To determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with aHUS in Korea.

Secondary objectives

* To determine the clinical prognosis of the disease in all patients with aHUS in Korea.
* To determine the clinical prognosis of the disease in patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea.
* To determine the treatment responses by treatment options in patients with aHUS in Korea.
* To identify risk factors that affect mortality in all patients with aHUS in Korea.
* To investigate the recurrence and clinical prognosis in patients with aHUS in Korea when eculizumab is discontinued

Detailed Description

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As a retrospective, non-interventional, multi-center study

Conditions

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aHUS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients who are clinically diagnosed with the aHUS

Exclusion Criteria

* Patients who are diagnosed with Shiga toxin-producing E. coli hemolytic-uremic syndrome (STEC-HUS).
* Patients with less than 10% in a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) activity test
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-501

Identifier Type: -

Identifier Source: org_study_id

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