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

Hepatitis B Clinical Trial

Official title:

The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310787
• Other study ID #: PL12
• Status: Recruiting
• Start date: May 15, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: October 2021
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Lu Wang, Doctor
• Phone: +8618814369232
• Email: wanglu910525[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Failure

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	Adverse events included decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death.	5 years