GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver (GSP)
Primary Purpose
Galactose Single Point (GSP), Residual Liver Function
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
Sponsored by
About this trial
This is an interventional screening trial for Galactose Single Point (GSP), Residual Liver Function focused on measuring GSP, galactose single point (GSP)
Eligibility Criteria
Inclusion Criteria:
Subject must fulfill all of the following criteria to be eligible for the study:
- Male or female with age between 20-80.
- Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Exclusion Criteria:
Any of the following criteria will disqualify the subject from participation:
- History of serious allergic reaction to galactose and have galactosemia.
- History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
- History of diabetes mellitus.
- Subjects are children or handicapped people.
- Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GSP measurement
Arm Description
For the GSP measurement, subjects will be Intravenous administered with 1.25 ml/kg G.S.P. solution (400 mg/ml of galactose) to subjects after I.V. G.SP. solution within 3 to 5 minutes. Sixty minutes after- G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of GSP value.
Outcomes
Primary Outcome Measures
Blood concentration of galactose
To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
Secondary Outcome Measures
Full Information
NCT ID
NCT04546022
First Posted
September 6, 2020
Last Updated
September 10, 2020
Sponsor
National Defense Medical Center, Taiwan
Collaborators
Cardinal Tien Hospital, Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04546022
Brief Title
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Acronym
GSP
Official Title
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2007 (Actual)
Primary Completion Date
August 12, 2007 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
Collaborators
Cardinal Tien Hospital, Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Galactose Single Point (GSP), Residual Liver Function
Keywords
GSP, galactose single point (GSP)
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSP measurement
Arm Type
Other
Arm Description
For the GSP measurement, subjects will be Intravenous administered with 1.25 ml/kg G.S.P. solution (400 mg/ml of galactose) to subjects after I.V. G.SP. solution within 3 to 5 minutes. Sixty minutes after- G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of GSP value.
Intervention Type
Drug
Intervention Name(s)
Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
Primary Outcome Measure Information:
Title
Blood concentration of galactose
Description
To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
Time Frame
Sixty minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must fulfill all of the following criteria to be eligible for the study:
Male or female with age between 20-80.
Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Exclusion Criteria:
Any of the following criteria will disqualify the subject from participation:
History of serious allergic reaction to galactose and have galactosemia.
History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
History of diabetes mellitus.
Subjects are children or handicapped people.
Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.
12. IPD Sharing Statement
Learn more about this trial
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
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