Galactose Single Point (GSP), Residual Liver Function Clinical Trial
Official title:
Clinical Phase Ⅲ Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
The primary objective is to determine the oral galactose single point (OGSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between OGSP and other hepatic function assessment methods among this trial subjects.
A novel, simple, clinically useful quantitative liver function test, called the galactose
single point (GSP) method, was developed to assess residual liver function by measuring
galactose blood concentration 1 hour after galactose was administered (0.5 g/kg). The
galactose single point (GSP) method has been used to evaluate liver function in both humans
and rats, and GSP concentration has been found to closely reflect changes in enzyme activity
and hepatic blood flow. The Federal Drug Administration of the U.S. has recommended the GSP
method in its guidelines for industry pharmacokinetics for patients with impaired hepatic
function (FDA 2003). The GSP method has also been successfully applied to measure the
clearance of drugs that are excreted from the liver but not metabolized, such as promazine
and cefoperazone, specifically in patients with various liver diseases. Hu et al.
demonstrated that GSP concentration is strongly correlated with the severity of liver
disease.
This translate the traditional GSP method to oral galactose single point (OGSP) that will
greatly improve the technical simplicity and reduce the burden to patients and will easily
applied to patient both in hospital and home to measure the residual liver function.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04546022 -
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
|
Phase 1/Phase 2 |