Clinical Trials

Severe AH continues to be associated with a high mortality and represents a significant public health burden. Prednisone is the standard of care but is associated with a modest and transient survival benefit at best and increased risk of severe bacterial and fungal infections. A recent large study indicated that pentoxifylline is not significantly superior to placebo. While several new targets are being evaluated, they are not sufficiently powered to provide definitive data.

The purpose of this study is to create a clinical database and bio-repository by obtaining blood, urine, and stool samples (e.g., biological samples) and personal health information from patients to use in future research studies related to alcoholic hepatitis or other diseases.

Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual ...

The purpose of this study is to determine if extracellular (EV) counts and content can differentiate Alcoholic Hepatitis (AH) from alcoholic liver disease as well as end stage liver disease due to other causes.

The purpose of this study is to evaluate the safety and effectiveness, as determined by 90-day incidence of mortality or transplant, for intravenous (IV) DUR-928 (30 mg or 90 mg) in subjects with severe alcohol-associated hepatitis, also known as severe alcoholic hepatitis, (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30. Additionally, to evaluate the effectiveness, as determined by 90-day mortality and 28-day mortality with or without transplant for IV DUR-928 (30 mg or 90 mg) in subjects with severe AH.

The purpose of this study is to evaluate the safety of acamprosate in individuals with alcohol-use disorder (AUD) and alcohol-related liver disease.

The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

The purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed.