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NCT04975490 Clinical Trial

Characterization and Pathogenesis of ACLF

Liver Cirrhosis Clinical Trial

— ACLF-I  

Official title:
Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04975490
Other study ID # ACLF-Initiative
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2025

Study information
Verified date July 2021
Source Johann Wolfgang Goethe University Hospital
Contact Jonel Trebicka, MD, PhD
Phone +4963014256
Email jonel.trebicka@kgu.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Liver cirrhosis Exclusion Criteria: - extrahepatic and metastatic malignancy, - refusal for participation - decision of attending phycisian

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Translational Hepatology Frankfurt Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality number of patients 90 days
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