Status:
UNKNOWN
Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
Lead Sponsor:
Richever Enterprise Co., Ltd.
Conditions:
Galactose Single Point (GSP), Residual Liver Function
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief 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 correlati...
Detailed 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 concen...
Eligibility Criteria
Inclusion
- Subject must fulfill all of the following criteria to be eligible for the study:
- Male or female with age between 20-85.
- Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03457311
Start Date
September 9 2013
End Date
March 31 2018
Last Update
March 7 2018
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