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RecruitingNCT04310787Updated Nov 29, 2024

Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

An observational study in Hepatitis B and Acute-On-Chronic Liver Failure, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started May 2020; still recruiting 6 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Chronic acute liver failure (ACLF) is a systemic multi-organ failure driven by acute liver injury in the basis of chronic liver disease. The main cause of chronic acute liver failure in China is hepatitis b virus infection.Previous studies on the prognosis of acute on-chronic liver failure mainly focused on the short-term survival rate and the follow-up time was relatively short, while the study on the long-term prognosis of patients with spontaneous recovery of chronic acute liver failure was still lack-ing. Thus,this study mainly retrospectively analyzed the clinical data of patients with chronic hepatitis b related acute liver failure admitted to the department of infectious diseases, the third affiliated hospital of sun yat-sen university, and con-ducted telephone follow-up survey to analyze the long-term prognosis of patients with chronic hepatitis b related acute on-chronic liver failure.

02

Conditions studied

  • Hepatitis B
  • Acute-On-Chronic Liver Failure

Keywords

  • Hepatitis B
  • Acute-On-Chronic Liver Failure
  • Prognosis
03

In context

Hepatitis B

1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.

This study's planned enrollment of 300 is below the median of 395 across 410 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • Other conditions that the researchers judged not appropriate for inclusion.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • HBV-ACLF

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

06

What researchers measure

Primary outcomes

  1. adverse events

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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510630, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2020 (actual). Primary completion is estimated for Dec 2024, 55 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2020
First posted
Mar 17, 2020
StartActual
May 15, 2020
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04310787
Responsible party
Liang Peng (Professer, Third Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Mar 17, 2020
Start date
May 15, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 29, 2024

Study contacts

Lu Wang, Doctor
Contact
wanglu910525@163.com
+8618814369232
Liang Peng, Doctor
Contact
pzp33@hotmail.com
+8613533978874
Liang Peng, Doctor
principal investigator · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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