NCT06865898

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28 days, 90 days

Secondary Outcomes (1)

  • Differential protein levels

    28 days, 90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 10, 2025

Record last verified: 2024-09

Locations