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RecruitingNCT04975490ACLF-IUpdated Jul 29, 2021

Characterization and Pathogenesis of ACLF

An observational study in Liver Cirrhosis, Acute-On-Chronic Liver Failure and Portal Hypertension, sponsored by Johann Wolfgang Goethe University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Dec 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups.

  1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
  2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets
  3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.
02

Conditions studied

  • Liver Cirrhosis
  • Acute-On-Chronic Liver Failure
  • Portal Hypertension
03

In context

Liver Cirrhosis

1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patient with liver cirrhosis and complications

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

  • Liver cirrhosis

Exclusion criteria

Exclusion Criteria:

  • extrahepatic and ,
  • refusal for participation
  • decision of attending phycisian
Terms in these criteria, in plain language(2)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • SAPIENT = Sepsis ACLF patients
  • PROACT = Portal mediators as ACLF Targets
  • ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts
06

What researchers measure

Primary outcomes

  1. Mortality

    number of patients

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Translational Hepatology
    Frankfurt, Hessen 60590, Germany
    Recruiting
    • Jonel Trebicka · Contact
08

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 Dec 2020 (actual). Primary completion is estimated for Sep 2025, 57 months after the start.

Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 57 months is above that.

Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.

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

Registered
Jul 14, 2021
First posted
Jul 23, 2021
StartActual
Dec 1, 2020
Primary completionEst.
Sep 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Jul 29, 2021
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 Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04975490
Responsible party
Jonel Trebicka (Principal Investigator and Coordinator, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Jul 23, 2021
Start date
Dec 1, 2020
Primary completion
Sep 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 29, 2021

Study contacts

Jonel Trebicka, MD, PhD
Contact
jonel.trebicka@kgu.de
+4963014256
Jonel Trebicka, MD, PhD
principal investigator · Goethe University Hospital Frankfurt

Oversight

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

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