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RecruitingNCT07438288SoLiDaRityUpdated Feb 27, 2026

Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis

An observational study in Cirrhosis and Chronic Liver Disease, sponsored by Singapore General Hospital. Recruiting at 3 sites in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Primary conditionAcute-On-Chronic Liver FailureRegistry: FibrosisReclassifiedWhy we changed it
Registry
Fibrosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acute-On-Chronic Liver Failure
Why
  1. Fibrosis is a broad heading, used only when no more specific condition is named.
  2. The study's title name Acute-On-Chronic Liver Failure.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Singapore General Hospital · Observational

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,200
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications.

This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.

Read the detailed description

The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis.

Specific goals of the study:

  • To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with compensated and decompensated liver cirrhosis in Singapore
  • To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, refractory ascites, sarcopenia, and liver cancer)
  • To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF and death in liver cirrhosis
  • To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, LSPS, PREDICT, etc).
  • To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, and pathogenesis of AD and ACLF
02

Conditions studied

  • Cirrhosis and Chronic Liver Disease

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Keywords

  • Cirrhosis
  • Decompensation
  • Acute-on-chronic liver failure
  • Death
03

In context

Acute-On-Chronic Liver Failure Reclassified

165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.

This study's planned enrollment of 2,200 is above the median of 226 across 64 observational studies indexed under Acute-On-Chronic Liver Failure.

Browse Acute-On-Chronic Liver Failure studies →

Lead sponsor

Singapore General Hospital is the lead sponsor of 270 studies on the registry; 57 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Acute-On-Chronic Liver Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This multicenter study aims to recruit 2,200 cirrhotic patients over a 5 year period from 3 institutions in SingHealth - Changi General Hospital (CGH), Sengkang General Hospital (SKH) and Singapore General Hospital (SGH).

Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion into the SoLiDaRity-DAM study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with clinical diagnosis of liver cirrhosis
  2. Age 18 years and above (parental consent required if below 21 years)
  3. Willing and able to provide

Exclusion criteria

Exclusion Criteria:

  • No clinical evidence of liver cirrhosis
  • Not willing to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,200 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Patients with liver cirrhosis

    Other: Observation

Interventions

  • OtherObservation

    Patients with liver cirrhosis will be observed to monitor for death

06

What researchers measure

Primary outcomes

  1. All cause mortality

    Death from any cause will be recorded during the study period

    Time frame: Up to 10 years from date of enrollment

Secondary outcomes

  1. Decompensation of liver cirrhosis

    Occurence of first episode of hepatic decompensation, defined as the development of any of the following clinical events: variceal bleeding, hepatic encephalopathy, ascites, hepatocellular carcinoma, portal vein thrombosis, sepsis and acute-on-chronic liver failure (ACLF). Diagnosis will be based on standard clinical, laboratory or imaging criteria. These data will be retrieved from hospital clinical records.

    Time frame: 10 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13. PubMed 32673741 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Anonymized data on baseline clinical characteristics and liver related outcomes

Supporting information: Study protocol, Informed consent form

Time frame: Aug 2022 to Aug 2027

Access criteria: Potential research collaborators (e.g. to publish meta-analysis or external validation studies)

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Aug 2027, 60 months after the start.

Of 38 observational studies under Acute-On-Chronic Liver Failure, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2025
First posted
Feb 27, 2026
StartActual
Aug 12, 2022
Primary completionEst.
Aug 12, 2027
CompletionEst.
Aug 12, 2032
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07438288
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Aug 12, 2022
Primary completion
Aug 12, 2027 (estimated)
Completion
Aug 12, 2032 (estimated)
Last update
Feb 27, 2026

Study contacts

Jason Pik Eu Chang, MBBS, MRCP
Contact
jason.chang@singhealth.com.sg
+65 6321 4684

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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