HBV Related Acute-on-chronic Liver FailureNCT06865898
Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology
An observational study of HBV Related Acute-on-chronic Liver Failure, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV Related Acute-on-chronic Liver Failure
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure
Who may be able to join
- HBV-LC patients were diagnosed based on previous liver biopsy results or clinical evidence and laboratory tests of previous decompensation for more than three months, including ascites, gastrointestinal bleeding, infection, hepatic encephalopathy, or a combination of these symptoms, endoscopic examination (esophageal and gastric varices), and radiological imaging of portal hypertension and/or liver nodules.
- The inclusion criteria for HBV-ACHD patients in this study were based on patients with chronic stable decompensated cirrhosis who experienced an acute decompensation within three months. The reference criteria for acute decompensation in the HBV-ACHD group were as follows: patients with previously diagnosed decompensated cirrhosis presenting with a high level of jaundice (total bilirubin ≥5 mg/dL) HBV-ACLF was categorized into three grades based on the severity of the condition. The inclusion criteria for HBV-ACLF-1 were as follows: patients presenting with liver failure alone with an international normalized ratio (INR) ≥1.5 and/or kidney dysfunction and/or hepatic encephalopathy (HE) grade I or II. HBV-ACLF-2 was defined by dual-organ system failure, while HBV-ACLF-3 was characterized by failure involving three or more organ systems.
Who cannot join
- Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics
Read the detailed description
The rationale for this study is that, with the changing epidemiology of liver diseases, traditional diagnostic methods are no longer sufficient to meet clinical needs. Olink technology, however, offers the potential to discover novel biomarkers. By comparing the plasma proteomic profiles of patients with cirrhosis and liver failure, we aim to identify clinically significant markers. This not only has the potential to enhance early diagnostic capabilities but also provides an important basis for personalized treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 days, 90 days
Secondary outcomes (1)
Differential protein levels
Measured: 28 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV Related Acute-on-chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865898
- Sponsor's protocol ID
- KYLL-202411-016-1
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology
- ClinicalTrials.gov ID
- NCT06865898
- Acronym / sponsor ID
- KYLL-202411-016-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Mar 2025 (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.
Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics
Detailed description
The rationale for this study is that, with the changing epidemiology of liver diseases, traditional diagnostic methods are no longer sufficient to meet clinical needs. Olink technology, however, offers the potential to discover novel biomarkers. By comparing the plasma proteomic profiles of patients with cirrhosis and liver failure, we aim to identify clinically significant markers. This not only has the potential to enhance early diagnostic capabilities but also provides an important basis for personalized treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure
Key inclusion criteria (2 listed)
- HBV-LC patients were diagnosed based on previous liver biopsy results or clinical evidence and laboratory tests of previous decompensation for more than three months, including ascites, gastrointestinal bleeding, infection, hepatic encephalopathy, or a combination of these symptoms, endoscopic examination (esophageal and gastric varices), and radiological imaging of portal hypertension and/or liver nodules.
- The inclusion criteria for HBV-ACHD patients in this study were based on patients with chronic stable decompensated cirrhosis who experienced an acute decompensation within three months. The reference criteria for acute decompensation in the HBV-ACHD group were as follows: patients with previously diagnosed decompensated cirrhosis presenting with a high level of jaundice (total bilirubin ≥5 mg/dL) HBV-ACLF was categorized into three grades based on the severity of the condition. The inclusion criteria for HBV-ACLF-1 were as follows: patients presenting with liver failure alone with an international normalized ratio (INR) ≥1.5 and/or kidney dysfunction and/or hepatic encephalopathy (HE) grade I or II. HBV-ACLF-2 was defined by dual-organ system failure, while HBV-ACLF-3 was characterized by failure involving three or more organ systems.
Key exclusion criteria (1 listed)
- Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
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
Mortality
Time frame: 28 days, 90 days
1 secondary outcome
Differential protein levels
Time frame: 28 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Related trials for HBV Related Acute-on-chronic Liver Failure
RecruitingObservational study
Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure
HBV Related Acute-on-chronic Liver Failure, HBV-related Liver Cirrhosis
RecruitingObservational study
Risk Factors Affecting MSC Efficacy in ACLF Patients
Acute-On-Chronic Liver Failure
Recruiting
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Hepatitis B, Acute-On-Chronic Liver Failure
RecruitingObservational study
Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF
Hepatitis B, Chronic, Acute-On-Chronic Liver Failure
RecruitingObservational study
Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
Hepatitis B, Acute-On-Chronic Liver Failure
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 HBV Related Acute-on-chronic Liver Failure, run by Qilu Hospital of Shandong University at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 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 China. 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?
Results are not available in the source record.
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?
Mortality (time frame: 28 days, 90 days). 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 10 Mar 2025.