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

NCT04546022 | Completed Phase 1 DMC

• 1 other identifier: GSP-001
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Galactose Single Point (GSP), Residual Liver Function

Keywords

GSP; galactose single point (GSP)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GSP measurement

OTHER

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.

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.

Interventions

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

GSP measurement

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead
• Cardinal Tien Hospital: collaborator
• Tri-Service General Hospital: collaborator

MeSH Terms

Conditions

Pseudohypoparathyroidism

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 11, 2020
• Study Start: July 5, 2007
• Primary Completion: August 12, 2007
• Study Completion: October 31, 2018
• Last Updated: September 14, 2020

Record last verified: 2020-09