Viewing Study NCT04546022



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Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04546022
Status: COMPLETED
Last Update Posted: 2020-09-14
First Post: 2020-09-06

Brief Title: GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Sponsor: National Defense Medical Center Taiwan
Organization: National Defense Medical Center Taiwan

Study Overview

Official Title: GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Status: COMPLETED
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GSP
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None