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Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology

Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06865898
Enrollment
58
Registered
2025-03-10
Start date
2023-03-01
Completion date
2025-03-31
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV Related Acute-on-chronic Liver Failure

Brief summary

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.

Interventions

None listed

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Mortality28 days, 90 days

Secondary

MeasureTime frame
Differential protein levels28 days, 90 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026