drugset / Trial / NCT00794716

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

NCT00794716

Phase 2 Completed 125 enrolled Norgine
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2008-06
Primary completion
2010-03
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject FLUORESCEIN LISICOL Diagnostic / imaging agent 2 mg Intravenous