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

Galactose Single Point (GSP), Residual Liver Function Clinical Trial

— GSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546022
• Other study ID #: GSP-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 5, 2007
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2020
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 31, 2018
• Est. primary completion date: August 12, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Subject must fulfill all of the following criteria to be eligible for the study:

1. Male or female with age between 20-80.

2. 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:

1. History of serious allergic reaction to galactose and have galactosemia.

2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.

3. History of diabetes mellitus.

4. Subjects are children or handicapped people.

5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan	Cardinal Tien Hospital, Tri-Service General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentration of galactose	To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function	Sixty minutes