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A Double-Blind, Placebo-Controlled Trial of Obeticholic Acid in Patients with Moderately Severe Alcoholic Hepatitis (AH)
Rochester, Minn.
The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.
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A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety and Efficacy Study of IMM 124-E (Hyperimmune Bovine Colostrum) for Patients with Severe Alcoholic Hepatitis
Rochester, Minn.
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.
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A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc), or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium (AlcHepNet02)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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.
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A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
Rochester, Minn.
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.
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Alcoholic Hepatitis Network Observational Study
Rochester, Minn.
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.
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Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
Rochester, Minn.,
La Crosse, Wis.,
Albert Lea, Minn.
To conduct a prospective, multicenter, observational study of patients with well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository will be developed from both cases and controls.
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Effects of NNC0194-0499 alone and in combination with semaglutide, of semaglutide alone, and of cagrilintide alone and in combination with semaglutide on liver health and alcohol use in people with alcohol-related liver disease
Rochester, Minn.
The purpose of this study is to investigate fixed doses of NNC0194-0499, Cagrilintide, Semaglutide alone and NNC0194-0499 or Cagrilintide in combination with Semalgutide versus placebo on liver damage and function in people with alcohol-related liver disease.
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Extracellular Counts and Content Can Diagnose Alcoholic Hepatitis
Rochester, Minn.
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.
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Feasibility of Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease
Rochester, Minn.
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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