Galactose Single Point (GSP), Residual Liver FunctionPhase 3NCT03457311
Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
A Phase 3 study testing G.S.P. Oral Solution 400 mg/ml in people with Galactose Single Point (GSP), Residual Liver Function, run by Richever Enterprise Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Galactose Single Point (GSP), Residual Liver Function
- What is being tested?
- G.S.P. Oral Solution 400 mg/ml
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2013to 31 Mar 2018
- Phase
- Phase 3
- 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 85 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 20-85.
- 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
Official title: Clinical Phase Ⅲ Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
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.
Read the 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 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.
- Being tested
- G.S.P. Oral Solution 400 mg/ml
- Keywords
- GSP, oral galactose single point (OGSP)
- Medical subject headings
- Pseudohypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G.S.P. Oral Solution 400 mg/mlDrug
Oral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| OGSP measurement | Other | For the OGSP measurement, subjects will be orally administered with 1.25 ml/kg G.S.P. oral solution (400 mg/ml of galactose). At least 20 ml water will be given to subjects after drinking G.S.P. oral solution within 3 to 5 minutes. Sixty minutes after oral G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of OGSP value. Receives: Drug: G.S.P. Oral Solution 400 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 posted7 Mar 2018
- Study start9 Sep 2013
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
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 3
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richever Enterprise Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457311
- Sponsor's protocol ID
- Oral GSP-001
- Status last verified
- Feb 2018
- First submitted
- 1 Mar 2018
- Last updated
- 7 Mar 2018
- 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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase Ⅲ Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
- ClinicalTrials.gov ID
- NCT03457311
- Acronym / sponsor ID
- Oral GSP-001
- Keywords
- GSP, oral galactose single point (OGSP)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Richever Enterprise Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 7 Mar 2018 (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 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.
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OGSP measurement | Other | Drug: G.S.P. Oral Solution 400 mg/mlFor the OGSP measurement, subjects will be orally administered with 1.25 ml/kg G.S.P. oral solution (400 mg/ml of galactose). At least 20 ml water will be given to subjects after drinking G.S.P. oral solution within 3 to 5 minutes. Sixty minutes after oral G.S.P. solution, a sample of 0.5 ml of whole blood will be taken from subject's finger for the determination of OGSP value. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| G.S.P. Oral Solution 400 mg/mlOral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours. | Drug | OGSP measurement |
Primary outcome
Blood concentration of oral galactose
Time frame: Sixty minutes
To determine the OGSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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 3 study testing G.S.P. Oral Solution 400 mg/ml in people with Galactose Single Point (GSP), Residual Liver Function, run by Richever Enterprise Co., Ltd..
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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 oral 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 7 Mar 2018.