CClinicalTrials.gg
Sign In
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

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

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

Inclusion criteria

  • Liver cirrhosis

Exclusion criteria

Exclusion Criteria:

  • extrahepatic and metastatic malignancy,
  • refusal for participation
  • decision of attending phycisian
04

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
05

What researchers measure

Primary outcomes

  1. Mortality

    number of patients

    Time frame: 90 days

06

Study locations

1 of 1 sites recruiting
  • Translational Hepatology
    Frankfurt, Hessen 60590, Germany
    • Jonel Trebicka · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT04975490
Lead sponsor
Johann Wolfgang Goethe University Hospital
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Cirrhosis→

Other studies from this sponsor

Johann Wolfgang Goethe University Hospital

Start the discussion