NCT07548190

Brief Summary

This study constitutes a bidirectional cohort investigation. By collating laboratory parameters and clinical data-including plasma and peripheral blood mononuclear cell (PBMC) analyses-from patients with acute-on-chronic liver failure, it aims to provide a reference framework for predicting prognosis and the occurrence of complications.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2018

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2018Dec 2026

Study Start

First participant enrolled

January 1, 2018

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 23, 2026

Status Verified

December 1, 2025

Enrollment Period

8.5 years

First QC Date

December 18, 2025

Last Update Submit

April 21, 2026

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint was all-cause mortality at days 28, 90, 180, and 360.

    Days 28, 90, 180, and 360

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients diagnosed with Hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) .

You may qualify if:

  • Clinical diagnosis of Hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF)

You may not qualify if:

  • age \< 18 years
  • extrahepatic organ failure unrelated to ACLF
  • active malignancy
  • co-infection with other hepatitis viruses or human immunodeficiency virus (HIV)
  • prior liver transplantation
  • use of immunosuppressants within 6 months before enrollment
  • unclear history of antiviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Shan Zhong, professor

    Department of Infectious Diseases, Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, The Second Affiliated Hospital, Chongqing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

April 23, 2026

Study Start

January 1, 2018

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)