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NCT Number: NCT06865898

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

Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 28 days, 90 days

Secondary outcomes

  1. Differential protein levels

    Time frame: 28 days, 90 days

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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