aHUSNCT05405777
A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea
An observational study of aHUS, run by Handok Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- aHUS
- How many people
- 97 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are clinically diagnosed with the atypical hemolytic uremic syndrome (aHUS).
Who may be able to join
- Patients who are clinically diagnosed with the aHUS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the detailed description
As a retrospective, non-interventional, multi-center study
- Conditions
- aHUS
- Keywords
- aHUS, eculizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical prognosis (Renal survival) by treatment with or without eculizumab
Renal survival (end-stage renal disease [ESRD]-free survival)
Measured: 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)
Measured: 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
Renal survival (ESRD-free survival)
Measured: 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
Overall survival (OS)
Measured: 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
Renal survival (ESRD-free survival)
Measured: 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
Overall survival (OS)
Measured: 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
Complete response of TMA
Measured: 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start4 Oct 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for aHUSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405777
- Sponsor's protocol ID
- HD-ECU-501
- Status last verified
- Jan 2025
- First submitted
- 13 May 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (aHUS) Patients in South Korea
- ClinicalTrials.gov ID
- NCT05405777
- Acronym / sponsor ID
- HD-ECU-501
- Conditions
- aHUS
- Keywords
- aHUS, eculizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are clinically diagnosed with the atypical hemolytic uremic syndrome (aHUS).
Key inclusion criteria (1 listed)
- Patients who are clinically diagnosed with the aHUS
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
5 secondary outcomes
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
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
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
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
Response rates of each treatment, compared to prior to start treatment
Time frame: 3rd and 6th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of aHUS, run by Handok Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.