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Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)

2014-08-27 03:26:08 | BioPortfolio

Summary

This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Non-Alcoholic Fatty Liver Disease

Intervention

NRL972

Location

Duke University Medical Center
Durham
North Carolina
United States
27710

Status

Recruiting

Source

Norgine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:08-0400

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Medical and Biotech [MESH] Definitions

Lipid infiltration of the hepatic parenchymal cells that is due to ALCOHOL ABUSE. The fatty changes in the alcoholic fatty liver may be reversible, depending on the amounts of TRIGLYCERIDES accumulated.

Liver diseases associated with ALCOHOLISM. It usually refers to the coexistence of two or more subentities, i.e., ALCOHOLIC FATTY LIVER; ALCOHOLIC HEPATITIS; and ALCOHOLIC CIRRHOSIS.

Fatty liver finding without excessive ALCOHOL CONSUMPTION.

Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS.

Cytoplasmic hyaline inclusions in HEPATOCYTES. They are associated with ALCOHOLIC STEATOHEPATITIS and non-alcoholic STEATOHEPATITIS, but are also present in benign and malignant hepatocellular neoplasms, and metabolic, toxic, and chronic cholestatic LIVER DISEASES.

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