CompletedNot Applicable

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

South Korea97 participantsStarted 2022-10-04

Plain-language 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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT05405777

SponsorHandok Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More aHUS trials