NCT04310787

Brief Summary

This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

4.6 years

First QC Date

March 13, 2020

Last Update Submit

November 26, 2024

Conditions

Keywords

Hepatitis BAcute-On-Chronic Liver FailurePrognosis

Outcome Measures

Primary Outcomes (1)

  • adverse events

    Adverse events included decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death.

    5 years

Study Arms (1)

HBV-ACLF

To investigate the clinical events and prognosis of patients with hepatitis b associated acute on-chronic liver failure

Eligibility Criteria

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

This study population were patients with hepatitis b-related acute on-chronic liver failure in the department of infectious diseases, the third affiliated hospital of sun yat-sen university.

You may qualify if:

  • Age from 18 to 65 years old;
  • The diagnosis consistent with hepatitis b associated chronic acute liver failure;
  • After hospitalization, the survival time \> 90 days;
  • The inpatient clinical data are complete.

You may not qualify if:

  • Human immunodeficiency virus infection or congenital immune deficiency diseases;
  • Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesLiver Failure, AcuteLiver FailureHepatic Insufficiency

Study Officials

  • Liang Peng, Doctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Peng, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

May 15, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be shared beginning 3 months and ending 5 years following the article publication.
Access Criteria
Proposals should be directed to xxx@yyy. To gain access, data requestors need to sign a data access agreement.

Locations