This clinical trial is focused on studying two serious liver conditions: severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF). Severe alcoholic hepatitis is a condition caused by excessive alcohol consumption, leading to liver inflammation. Acute-on-chronic liver failure is a syndrome that occurs in patients with chronic liver disease, characterized by sudden liver failure and potentially affecting other organs like the kidneys and brain. The study will test the safety of a new treatment combining two medications: Resatorvid (TAK-242), which is a selective inhibitor of TLR4-mediated signaling, and Granulocyte Colony-Stimulating Factor (G-CSF), a substance that helps the body produce more white blood cells. A placebo will also be used for comparison.
The purpose of this study is to evaluate the safety of the combination treatment in patients with these liver conditions. Participants will receive either the combination of Resatorvid and G-CSF, Resatorvid alone, or a placebo. The treatment will be administered over a period of up to 10 days. The study will monitor the participants for any side effects and assess the impact of the treatment on liver function and overall health. The trial aims to understand how the treatment affects inflammation, liver function, and the body’s ability to recover from liver failure.
Throughout the study, researchers will collect data on various health markers, including inflammation and liver function, to determine the effectiveness of the treatment. The study will also look at the quality of life of participants and the number of days they spend in intensive care. The ultimate goal is to find a safe and effective treatment option for patients suffering from severe alcoholic hepatitis and acute-on-chronic liver failure.



Germany
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Spain