Liver CirrhosisACLF-INCT04975490
Characterization and Pathogenesis of ACLF
An observational study of Liver Cirrhosis and Acute-On-Chronic Liver Failure, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Acute-On-Chronic Liver Failure, Portal Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 31 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with liver cirrhosis and complications
Who may be able to join
- Liver cirrhosis
Who cannot join
- extrahepatic and metastatic malignancy,
- refusal for participation
- decision of attending phycisian
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Translational Hepatology
Frankfurt am Main, Hesse, 60590
Jonel Trebicka
About this study
Official title: Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens
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.
- SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
- PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets
- 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.
- Medical subject headings
- Liver Cirrhosis, Acute-On-Chronic Liver Failure, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SAPIENT = Sepsis ACLF patients | Not described | |
| PROACT = Portal mediators as ACLF Targets | Not described | |
| ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
number of patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Dec 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonel Trebicka, Johann Wolfgang Goethe University Hospital
- Investigators
- Jonel Trebicka, MD, PhD, Principal investigator, Goethe University Hospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975490
- Sponsor's protocol ID
- ACLF-Initiative
- Acronym
- ACLF-I
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thiyagarajah K, Sonnenberg J, Gorgulu E, Lembeck P, Kraus N, Glitscher M, Uschner FE, Brol MJ, Gu W, Schierwagen R, Klein S, McCoy MS, Mucke MM, Wiedemann T, Reuken PA, Reissing J, Schneider F, Bohling N, Praktiknjo M, Tepasse PR, Fischer J, Zeuzem S, Welsch C, Ciesek S, Stallmach A, Trebicka J, Chang J, Bruns T, Hildt E, Peiffer KH. Higher prevalence of cytomegalovirus and Epstein-Barr virus in acute-on-chronic liver failure. JHEP Rep. 2026 Apr;8(4):101627. doi: 10.1016/j.jhepr.2025.101627. Epub 2025 Oct 9.
PubMed 41861678
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens
- ClinicalTrials.gov ID
- NCT04975490
- Acronym / sponsor ID
- ACLF-I / ACLF-Initiative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jul 2021 (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.
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.
- SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
- PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAPIENT = Sepsis ACLF patients | – | – |
| PROACT = Portal mediators as ACLF Targets | – | – |
| ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with liver cirrhosis and complications
Key inclusion criteria (1 listed)
- Liver cirrhosis
Key exclusion criteria (3 listed)
- extrahepatic and metastatic malignancy,
- refusal for participation
- decision of attending phycisian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 90 days
number of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 41861678Thiyagarajah K, Sonnenberg J, Gorgulu E, Lembeck P, Kraus N, Glitscher M, Uschner FE, Brol MJ, Gu W, Schierwagen R, Klein S, McCoy MS, Mucke MM, Wiedemann T, Reuken PA, Reissing J, Schneider F, Bohling N, Praktiknjo M, Tepasse PR, Fischer J, Zeuzem S, Welsch C, Ciesek S, Stallmach A, Trebicka J, Chang J, Bruns T, Hildt E, Peiffer KH. Higher prevalence of cytomegalovirus and Epstein-Barr virus in acute-on-chronic liver failure. JHEP Rep. 2026 Apr;8(4):101627. doi: 10.1016/j.jhepr.2025.101627. Epub 2025 Oct 9.
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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.
Jonel Trebicka, MD, PhD principal investigator
Goethe University Hospital Frankfurt
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 Liver Cirrhosis and Acute-On-Chronic Liver Failure, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 1 inclusion and 3 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 29 Jul 2021. 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 Germany. 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 Jonel Trebicka, MD, PhD (+4963014256, jonel.trebicka@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04975490, which also lists 1 linked publication.
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 29 Jul 2021.