Acute-on-Chronic Liver Failure (ACLF)NCT07815418
The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients
An observational study of Acute-on-Chronic Liver Failure (ACLF) and hepatitisB, run by Tongji Hospital at 1 site in China.
Trial summary
This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-on-Chronic Liver Failure (ACLF), hepatitisB, Treatment
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research population is CHB patients who have a diagnosis of ACLF according to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)
Who may be able to join
- Age 18-70;
- Hepatitis B surface antigen positive ≥ 6 months;
- TBil>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA < 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL))
Who cannot join
- Patients with malignant liver tumors and other tumors;
- Pregnant or lactating women;
- Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease;
- Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
- Patients with other organ dysfunction or failure;
- Combined using more than one NAs drug
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.
Read the detailed description
NAs drugs play an important role in the treatment of HBV-ACLF. Currently, multiple research results indicate that the use of NAs can significantly improve the prognosis of HBV-ACLF patients, and the rapid decrease in early viral load is closely related to better prognosis. Compared to ETV and TDF, two early marketed NAs drugs, there is limited research on the prognosis and safety of TAF and TMF in HBV-ACLF patients, and head to head studies on the treatment of HBV-ACLF with various commonly used NAs drugs are even rarer. In addition, how novel virological markers change in HBV-ACLF patients after NAs treatment and whether there is a correlation with patient prognosis is also an unexplored topic. Therefore, this study aims to analyze the changes in clinical indicators and viral markers in HBV-ACLF patients during hospitalization, combined with the patient's prognosis, to explore the dynamic changes of novel virological markers during HBV-ACLF treatment, as well as the safety and impact of different NAs drugs on the prognosis of HBV-ACLF treatment.
- Conditions
- Acute-on-Chronic Liver Failure (ACLF), hepatitisB, Treatment
- Keywords
- antiviral treatment, HBV-ACLF, prognosis
- Medical subject headings
- 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 |
|---|---|---|
| ETV group | HBV-ACLF patients treated with ETV after admission | |
| TAF group | HBV-ACLF patients treated with TAF after admission | |
| TMF group | HBV-ACLF patients treated with TMF after admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day survival rate of patients (%)
Survival status of patients 60 days after admission
Measured: 60 days
Secondary outcomes (1)
24-week HBV DNA negativity rate (%)
HBV DNA negative rate(%) at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Feb 2022
- Primary completion1 Apr 2024
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-on-Chronic Liver Failure (ACLF)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meifang Han, Tongji Hospital
- Investigators
- Meifang Han, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815418
- Sponsor's protocol ID
- TJ-202403051
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients
- ClinicalTrials.gov ID
- NCT07815418
- Acronym / sponsor ID
- TJ-202403051
- Conditions
- Acute-on-Chronic Liver Failure (ACLF), hepatitisB, Treatment
- Keywords
- antiviral treatment, HBV-ACLF, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 11 Sep 2026 (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 is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.
Detailed description
NAs drugs play an important role in the treatment of HBV-ACLF. Currently, multiple research results indicate that the use of NAs can significantly improve the prognosis of HBV-ACLF patients, and the rapid decrease in early viral load is closely related to better prognosis. Compared to ETV and TDF, two early marketed NAs drugs, there is limited research on the prognosis and safety of TAF and TMF in HBV-ACLF patients, and head to head studies on the treatment of HBV-ACLF with various commonly used NAs drugs are even rarer. In addition, how novel virological markers change in HBV-ACLF patients after NAs treatment and whether there is a correlation with patient prognosis is also an unexplored topic. Therefore, this study aims to analyze the changes in clinical indicators and viral markers in HBV-ACLF patients during hospitalization, combined with the patient's prognosis, to explore the dynamic changes of novel virological markers during HBV-ACLF treatment, as well as the safety and impact of different NAs drugs on the prognosis of HBV-ACLF treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ETV group | – | –HBV-ACLF patients treated with ETV after admission |
| TAF group | – | –HBV-ACLF patients treated with TAF after admission |
| TMF group | – | –HBV-ACLF patients treated with TMF after admission |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research population is CHB patients who have a diagnosis of ACLF according to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)
Key inclusion criteria (3 listed)
- Age 18-70;
- Hepatitis B surface antigen positive ≥ 6 months;
- TBil>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA < 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL))
Key exclusion criteria (6 listed)
- Patients with malignant liver tumors and other tumors;
- Pregnant or lactating women;
- Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease;
- Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
- Patients with other organ dysfunction or failure;
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
60-day survival rate of patients (%)
Time frame: 60 days
Survival status of patients 60 days after admission
1 secondary outcome
24-week HBV DNA negativity rate (%)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
Not yet recruitingPhase 1/2
RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
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. This study is not recruiting at the moment.
Meifang Han, Doctor principal investigator
Tongji Hospital
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 Acute-on-Chronic Liver Failure (ACLF) and hepatitisB, run by Tongji Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 11 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day survival rate of patients (%) (time frame: 60 days). 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 11 Sep 2026.