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Clinical Trial Summary

The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between GSP and other hepatic function assessment methods among this trial subjects.


Clinical Trial Description

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose single point (GSP) test which recommended by the US FDA to quantitatively measure liver function in patients with NAFLD. ;


Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • Galactose Single Point (GSP), Residual Liver Function

NCT number NCT04546022
Study type Interventional
Source National Defense Medical Center, Taiwan
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 5, 2007
Completion date October 31, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03457311 - Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®) Phase 3