Acute on Chronic Liver FailureNCT04054037
A Study of AARC Standards on Diagnosis and Treatment of Patients With HBV-ACLF in China (AARC China Study)
An observational study of Acute on Chronic Liver Failure and HBV, run by Qin Ning at 1 site in China.
Trial summary
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute on Chronic Liver Failure, HBV
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2019to 1 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HBV-related acute-on-chronic liver failure
Who may be able to join
- Chronic liver disease: Chronic hepatitis B
- Acute deterioration of liver function: more than one of the below criteria
- development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria)
- development of hepatic encephalopathy
- development of gastrointestinal hemorrhage
- development of jaundice (serum bilirubin greater than or equal to 3mg/dl)
Show all 17Show fewer
- development of bacterial infection
- spontaneous bacteremia: positive blood cultures without a source of infection
- spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells >250/µL
- lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38_C or less than 36_C, shivering, or leukocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics
- Clostridium difficile Infection: diarrhea with a positive C. difficile assay
- bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli;
- soft-tissue/skin Infection: fever with cellulitis
- urinary tract infection (UTI): urine white blood cell >15/high-power field with either positive urine gram stain or culture;
- intra-abdominal infections: diverticulitis, appendicitis, cholangitis, etc.
- other infections not covered above;
- fungal infections as a separate category.
Who cannot join
- Patients who do not have chronic liver disease
- Patients who have hepatocellular carcinoma
- Patients who admitted for extrahepatic manifestations
- Patients who have HIV infection
- Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Ning, Prof., 862883662391, qning@vip.sina.com
About this study
Official title: A Study of APASL ACLF Research Consortium (AARC) Standards on Diagnosis and Treatment of Patients With Hepatic B Virus Related Acute on Chronic Liver Failure (HBV-ACLF) in China (AARC China Study)： a Multicentre Prospective Cohort Study
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
Read the detailed description
Acute on chronic liver failure (ACLF) is a clinically critical illness and has been extensively researched around the world. However, there is a potential "communication barrier" in the ACLF study; that is, different countries and regions, or different research collaboration groups, follow different ACLF definitions and related standards, making researchers in this field confuse in understanding the research value of relevant research and interpreting the research results. Important differences exist in the Asia-Pacific region and North America and Europe, such as the etiology, the clinical characteristics of the patient group, the requirements for cirrhosis, and the predisposing factors of the disease, making it necessary for China or the Asia-Pacific region to develop appropriate ACLF diagnosis standards and prognosis. In recent years, Chinese experts have also focused on the research progress of APASL ACLF Research Consortium (AARC) in the Asia-Pacific region. It is found that the AARC standards are more suitable for the diagnosis and treatment of patients with ACLF in China than the Western standards. The ACLF prediction model (TPPM model) established by Professor Qin.N's team predicts that the prognostic efficacy of patients with HBV-ACLF is significantly better than that of Western prognosis. The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
- Conditions
- Acute on Chronic Liver Failure, HBV
- Being tested
- No intervention
- Keywords
- APASL ACLF Research Consortium, Diagnosis and treatment standard, HBV-ACLF, acute on chronic liver failure
- Medical subject headings
- Acute-On-Chronic Liver Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observation study, no intervention will be indicated during diagnosis and treatment.
| Study group | Role | What they receive |
|---|---|---|
| HBV-ACLF Group | Patients with HBV related acute on chronic liver failure Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-liver transplant mortality
Non-liver transplant mortality rate at 30 days, 90 days
Measured: 30 days, 90 days
Secondary outcomes (1)
progression of Chronic liver disease
Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start2 Jul 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
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 FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, MD., PhD., Study director, Department of Infectious Disease, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054037
- Sponsor's protocol ID
- AARC China Study
- Status last verified
- Aug 2019
- First submitted
- 13 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of APASL ACLF Research Consortium (AARC) Standards on Diagnosis and Treatment of Patients With Hepatic B Virus Related Acute on Chronic Liver Failure (HBV-ACLF) in China (AARC China Study)： a Multicentre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04054037
- Acronym / sponsor ID
- AARC China Study
- Conditions
- Acute on Chronic Liver Failure, HBV
- Keywords
- APASL ACLF Research Consortium, Diagnosis and treatment standard, HBV-ACLF, acute on chronic liver failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 13 Aug 2019 (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.
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
Detailed description
Acute on chronic liver failure (ACLF) is a clinically critical illness and has been extensively researched around the world. However, there is a potential "communication barrier" in the ACLF study; that is, different countries and regions, or different research collaboration groups, follow different ACLF definitions and related standards, making researchers in this field confuse in understanding the research value of relevant research and interpreting the research results. Important differences exist in the Asia-Pacific region and North America and Europe, such as the etiology, the clinical characteristics of the patient group, the requirements for cirrhosis, and the predisposing factors of the disease, making it necessary for China or the Asia-Pacific region to develop appropriate ACLF diagnosis standards and prognosis. In recent years, Chinese experts have also focused on the research progress of APASL ACLF Research Consortium (AARC) in the Asia-Pacific region. It is found that the AARC standards are more suitable for the diagnosis and treatment of patients with ACLF in China than the Western standards. The ACLF prediction model (TPPM model) established by Professor Qin.N's team predicts that the prognostic efficacy of patients with HBV-ACLF is significantly better than that of Western prognosis. The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV-ACLF Group | – | Other: No interventionPatients with HBV related acute on chronic liver failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HBV-related acute-on-chronic liver failure
Key inclusion criteria (17 listed)
- Chronic liver disease: Chronic hepatitis B
- Acute deterioration of liver function: more than one of the below criteria
- spontaneous bacteremia: positive blood cultures without a source of infection
- spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells >250/µL
- lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38_C or less than 36_C, shivering, or leukocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics
Key exclusion criteria (5 listed)
- Patients who do not have chronic liver disease
- Patients who have hepatocellular carcinoma
- Patients who admitted for extrahepatic manifestations
- Patients who have HIV infection
- Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observation study, no intervention will be indicated during diagnosis and treatment. | Other | HBV-ACLF Group |
Primary outcome
Non-liver transplant mortality
Time frame: 30 days, 90 days
Non-liver transplant mortality rate at 30 days, 90 days
1 secondary outcome
progression of Chronic liver disease
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Qin Ning, MD., PhD. study director
Department of Infectious Disease, 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 and HBV, run by Qin Ning 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 17 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Ning, MD., PhD. (0086 2783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-liver transplant mortality (time frame: 30 days, 90 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 13 Aug 2019.