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Completed

NCT Number: NCT05405777

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

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

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Key information

Conditions

aHUS

Sex eligibility

All sexes

Study type

Observational

Primary location

Handok

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical prognosis (Renal survival) by treatment with or without eculizumab

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first

    Renal survival (end-stage renal disease [ESRD]-free survival)

  2. Clinical prognosis (Overall survival) by treatment with or without eculizumab

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first

    Overall survival (OS)

Secondary outcomes

  1. Clinical prognosis (Renal survival) of all aHUS patients in Korea

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first

    Renal survival (ESRD-free survival)

  2. Clinical prognosis (Overall survival) of all aHUS patients in Korea

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first

    Overall survival (OS)

  3. Clinical prognosis (Renal survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first

    Renal survival (ESRD-free survival)

  4. Clinical prognosis (Overall survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea

    Time frame: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first

    Overall survival (OS)

  5. Response rates of each treatment, compared to prior to start treatment

    Time frame: 3rd and 6th months

    Complete response of TMA

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (aHUS) Patients in South Korea

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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