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

NCT05405777 | Completed

• 1 other identifier: HD-ECU-501
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

aHUS

Keywords

aHUS; eculizumab

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (5)

• 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

• 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

• 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

• Response rates of each treatment, compared to prior to start treatment

  3rd and 6th months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who are clinically diagnosed with the aHUS

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 6, 2022
• Study Start: October 4, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (1)