NCT06865859

Brief Summary

This study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

November 1, 2023

Completed
1.3 years 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 10, 2025

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

HBV Related Acute-on-chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28 days, 90 days

Study Arms (4)

Chronic Hepatitis B

HBV related liver cirrhosis

HBV related acute-on-chronic hepatic dysfunction

HBV related acute-on-chronic liver failure

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 chronic hepatitis B，HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure

You may qualify if:

  • Acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an INR ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and liver tissue

Central Study Contacts

Yu-Chen Fan

CONTACT

0086+053182169593fanyuchen@sdu.edu.cn

Study Design

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

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

November 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

March 10, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)