Characterization and Pathogenesis of ACLF | NCT04975490

Studies
Characterization and Pathogenesis of ACLF

NCT04975490

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Liver Cirrhosis
Acute-On-Chronic Liver Failure
Portal Hypertension

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 14, 2021

First Submission Date that Met QC Criteria

Jul 14, 2021

First Posted Date

Jul 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2021

Last Update Posted Date

Jul 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jonel Trebicka, Principal Investigator and Coordinator, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAPIENT = Sepsis ACLF patients
PROACT = Portal mediators as ACLF Targets
ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	number of patients	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Liver cirrhosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with liver cirrhosis and complications

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonel Trebicka, MD, PhD	Contact	+4963014256		jonel.trebicka@kgu.de

Overall Officials

Name	Affiliation	Role
Jonel Trebicka, MD, PhD	Goethe University Hospital Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Translational Hepatology	Recruiting	Frankfurt am Main	Hesse	60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41861678	Derived	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.

ID	Term
D008103	Liver Cirrhosis
D065290	Acute-On-Chronic Liver Failure
D006975	Hypertension, Portal

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes