Adults 15 to 79, any sex, with Liver Failure, Acute on Chronic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation RatePrimary· up to 28 days
liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant.
28-day Mortality
Group
Value
95% CI
Acute-on-Chronic Liver Disease
74
28-day Liver Transplantation Rate at 28 days
Group
Value
95% CI
Acute-on-Chronic Liver Disease
124
28-day liver transplantation free mortality
Group
Value
95% CI
Acute-on-Chronic Liver Disease
74
90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation RateSecondary· up to 90 days
liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant.
90-day mortality rate
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
333
90-day liver transplantation rate
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
171
90-day liver transplantation free mortality
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
333
180-day Mortality Rate and Liver Transplantation RateSecondary· up to 180 days
Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively.
180-day mortality rate
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
403
180-day liver transplantation rate
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
177
180-day liver transplantation free mortality'
Group
Value
95% CI
Acute-on-Chronic Liver Disease Inpatients
403
The Appearance and Number of Organ FailureSecondary· Up to 28 days
The appearance and number of organ failure（including liver, coagulation, renal, circulation, brain, respiratory system） will be evaluated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit)during patients' hospitalization.
Group
Value
95% CI
Acute-on-Chronic Liver Disease
261
Serum BilirubinSecondary· Up to 28 days
be collected and reported at 28 or last visit before discharge
Group
Value
95% CI
Acute-on-Chronic Liver Disease
9.3
± 10.32
Sponsor's own description
Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute deterioration of liver function, culminating in multiple organs failure and high short-term mortality. Currently, there are differences in definitions and descriptions between western and eastern types of ACLF, especially in the definition of chronic liver disease and its precipitating events. The CANONIC (EASL-CLIF ACLF in Cirrhosis) study put forward CLIF-SOFA (chronic liver failure-sequential organ failure assessment) scores as the clinical diagnostic criteria of ACLF in 2013. Although the Asian Pacific Association for the Study of the Liver (APASL) reached a consensus for diagnostic criteria of ACLF in 2008, it is based on expert opinion. This prospective multicenter clinical trial is launched to clarify the eastern type of ACLF (HBV related) and estimate whether the eastern and western (alcoholic related) types are homogenous. 3 key points of concern are: (1) Whether HBV and non-HBV ACLFs are belonged to a homogenous disease entity which share the same diagnostic criteria, disease grades classification and prognostic model? (2) Whether acute deteriorating patients from cirrhosis or from mild fibrosis (S1-S2) belong to a homogenous entity? (3) To clarify if there are heterogenous groups in APASL criteria diagnosed ACLF patients.
14 Chinese national wide liver centers have been included. Continuous hospitalized chronic liver disease patients of various etiologies (including both cirrhotic and non-cirrhotic) with acute decompensation (AD) or acute hepatic injury (ALI) (aminotransferase \> 3NL(normal level)) will be recruited from January to December 2015. Biochemical parameters, organ failure will be collected and evaluated at day 1,4,7,14,21 and 28 after enrollment. Patients'death and LT (liver transplantation) are the primary and secondary endpoints of observation. Mortality and LT rate will be calculated at 28 days,90 days,180 days,1 year and 2 years after enrollment. Considering there will lack of liver biopsy in most of the patients, both CT and FibroScan as supplementary methods to differentiate non-cirrhotic patients. The patients will be continuously followed up once a month until the 24th month after hospital discharging and follow similar hospitalization process again whenever they have new ALI or AD. Data about the patients from stable chronic liver disease to deterioration will be acquired analyzed according to the questions hoped to resolve.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hai Li
Last refreshed: 11 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02457637.