Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)

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®)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03457311
• Other study ID #: Oral GSP-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 1, 2018
• Last updated: March 6, 2018
• Start date: September 9, 2013
• Est. completion date: March 31, 2018

Study information

• Verified date: February 2018
• Source: Richever Enterprise Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 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 20-85.

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

• Galactose Single Point (GSP), Residual Liver Function

Intervention

Drug:
• G.S.P. Oral Solution 400 mg/ml
Oral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Richever Enterprise Co., Ltd.

Outcome

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