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

Sponsor
Handok Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05405777
Collaborator
(none)
70
Enrollment
2.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (aHUS) Patients in South Korea
    Anticipated Study Start Date :
    Jun 14, 2022
    Anticipated Primary Completion Date :
    Aug 31, 2022
    Anticipated Study Completion Date :
    Aug 31, 2022

    Outcome Measures

    Primary Outcome Measures

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

    1. Clinical prognosis (Renal survival) of all aHUS patients in Korea [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 [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 [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 [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 [3rd and 6th months]

      Complete response of TMA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Handok Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Handok Inc.
    ClinicalTrials.gov Identifier:
    NCT05405777
    Other Study ID Numbers:
    • HD-ECU-501
    First Posted:
    Jun 6, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Handok Inc.
    aHUS
    eculizumab

    Study Results

    No Results Posted as of Jun 6, 2022