Galactose Single Point (GSP), Residual Liver FunctionPhase 1/2GSPNCT04546022
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
A Phase 1/2 study testing Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours. in people with Galactose Single Point (GSP), Residual Liver Function, run by National Defense Medical Center, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Galactose Single Point (GSP), Residual Liver Function
- What is being tested?
- Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2007to 31 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Being tested
- Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
- Keywords
- GSP, galactose single point (GSP)
- Medical subject headings
- Pseudohypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of galactose
To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
Measured: Sixty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start5 Jul 2007
- Primary completion12 Aug 2007
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Galactose Single Point (GSP), Residual Liver FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Tien Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Principal investigator, Tung Yuan Shih, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546022
- Sponsor's protocol ID
- GSP-001
- Acronym
- GSP
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
- ClinicalTrials.gov ID
- NCT04546022
- Acronym / sponsor ID
- GSP / GSP-001
- Keywords
- GSP, galactose single point (GSP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Cardinal Tien Hospital, Tri-Service General Hospital (TSGH)
- Study start
- 5 Jul 2007 (actual)
- Primary completion
- 12 Aug 2007 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSP measurement | Other | 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.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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Blood concentration of galactose
Time frame: Sixty minutes
To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours. in people with Galactose Single Point (GSP), Residual Liver Function, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentration of galactose (time frame: Sixty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020; AzTrials last refreshed its copy on 31 Oct 2026.