CTIS.eu › Conditions › 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 resulting in liver failure (jaundice and prolongation of INR), one or more extrahepatic organ failures (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. The study population will consist of up to 78 subjects with Grade 1- 3 ACLF limited to 3 organ failures and a baseline CLIF-C ACLF-CRP score of >35 and <60.

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 resulting in liver failure (jaundice and prolongation of INR), one or more extrahepatic organ failures (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. The study population will consist of up to 78 subjects with Grade 1- 3 ACLF limited to 3 organ failures and a baseline CLIF-C ACLF-CRP score of >35 and <60.

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Phase2, double-blind, randomized, placebo-controlled, multicentre study to evaluation the safety, efficacy, and pharmacokinetics of TAK-242 … Not authorised

2022-501026-37-00 4

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