Alcoholic hepatitis

Displaying 10 studies

  • Trial of Anakinra (Plus Zinc), or Prednisone in Patients With Severe Alcoholic Hepatitis Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

  • Safety and Efficacy of IMM 124-E for Patients with Severe Alcoholic Hepatitis Rochester, MN

    Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH).

    Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm 124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on steroids.

  • Study of IDN-6556 in Patients With Severe AH and Contradictions to Steroid Therapy Rochester, MN

    The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.

  • A Study to Establish an Alcoholic Hepatitis Network Rochester, MN

    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.

  • Use of F-652 in Patients With Alcoholic Hepatitis Mankato, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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 ...

  • A Study to Evaluate Whether or Not Extracellular Counts and Content Can Diagnose Alcoholic Hepatitis Rochester, MN

    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.

  • A Study to Evaluate the Safety of Acamprosate for Alcohol Use Disorder Mankato, MN; Rochester, MN

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

  • A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated Cirrhotic Patients Rochester, MN

    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. 

  • A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia Scottsdale/Phoenix, AZ

    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.

  • A Study to Evaluate Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease Rochester, MN

    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.

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