A-TANGO Phase 2 Study

The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe. Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \>15% risk of mortality at 28 days. Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \[severe alcoholic hepatitis (sAH)\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.

NCT Number	NCT06890039
Lead Sponsor	Yaqrit Ltd Collaborators: European Foundation for Study of Chronic Liver Failure, University College, London, HEPYX LIMITED, CROWDHELIX LIMITED, Charite University, Berlin, Germany, University of Leipzig, Concentris research management gmbh, Assistance Publique - Hôpitaux de Paris, Leiden University Medical Center, INTERNATIONAL MARKET ACCESS CONSULTING GMBH, KlinEra Global Services, European Association for the Study of the Liver, EUROPEAN LIVER PATIENTS' ASSOCIATION
Conditions	Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
Enrollment	78 participants
Start Date	2025-09-01
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-29