NCT04546022

GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Galactose Single Point (GSP), Residual Liver Function

Interventions

Type	Name	Description
DRUG	Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.

Timeline

• Start date: 2007-07-05
• Primary completion: 2007-08-12
• Completion: 2018-10-31
• First posted: 2020-09-11
• Last updated: 2020-09-14