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

June 2, 2022 updated by: Handok Inc.

A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are clinically diagnosed with the atypical hemolytic uremic syndrome (aHUS).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first
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)
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
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)
from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first
Response rates of each treatment, compared to prior to start treatment
Time Frame: 3rd and 6th months
Complete response of TMA
3rd and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 14, 2022

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HD-ECU-501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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