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

Handok Inc.1 site in 1 country97 target enrollmentOctober 4, 2022

ConditionsaHUS

Overview

Phase: N/A
Intervention: Not specified
Conditions: aHUS
Sponsor: Handok Inc.
Enrollment: 97
Locations: 1
Primary Endpoint: Clinical prognosis (Overall survival) by treatment with or without eculizumab
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 4, 2022

End Date

December 31, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Handok Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

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)
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)
Response rates of each treatment, compared to prior to start treatment(3rd and 6th months)
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)
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)