Hepatitis BNCT04310787
Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
An observational study of Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Acute-On-Chronic Liver Failure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
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.
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Keywords
- Hepatitis B, Acute-On-Chronic Liver Failure, Prognosis
- Medical subject headings
- Hepatitis B, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HBV-ACLF | To investigate the clinical events and prognosis of patients with hepatitis b associated acute on-chronic liver failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Adverse events included decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start15 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310787
- Sponsor's protocol ID
- PL12
- Status last verified
- Nov 2024
- First submitted
- 13 Mar 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04310787
- Acronym / sponsor ID
- PL12
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Keywords
- Hepatitis B, Acute-On-Chronic Liver Failure, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV-ACLF | – | –To investigate the clinical events and prognosis of patients with hepatitis b associated acute on-chronic liver failure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adverse events
Time frame: 5 years
Adverse events included decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
Related trials for Hepatitis B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang, Doctor (+8618814369232, wanglu910525@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.