End Stage Liver DiseasePhase 2NCT01907074
Quantitative Liver Function Tests Using Cholates
A Phase 2 study testing Cholates in people with End Stage Liver Disease, run by Baylor Research Institute at 1 site in United States.
Trial summary
As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Cholates
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2011to 20 May 2025
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease patients
- Age: 18 yr to 80 yr
- Patients or Legal Authorized Representative (LAR) must provide written consent and be willing and able to adhere to study requirements
- Stage 3-4 fibrosis by METAVIR score or clinical evidence of advanced fibrosis (End-stage liver disease patients only)
Who cannot join
- Hepatic encephalopathy Grade 3 or 4
- Pregnancy or intent to become pregnant
- Subjects with inability to provide consent for one's self
- Subjects with a life expectancy < 1 year
- Subjects who have participated in an investigational drug study within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for their outcomes. The traditional assessment of the liver patient has been limited to imaging, static measures of "liver function tests" and liver biopsy. This protocol is designed to increase the spectrum of tests in the evaluation of the patient with end stage liver disease.
Read the detailed description
This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2
This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient [HVPG] procedure.)
The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic
- Conditions
- End Stage Liver Disease
- Being tested
- Cholates
- Keywords
- liver function tests, end stage liver disease, cirrhosis, living liver donor
- Medical subject headings
- End Stage Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholatesDrug
Cholates is given intravenously (IV push) and by mouth, once per study visit
| Study group | Role | What they receive |
|---|---|---|
| Cholates Compound | Experimental | Not described Receives: Drug: Cholates |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness and accuracy of quantitative liver function testing using oral and IV cholate in patients with end-stage liver disease OR in patients who donate a portion of their liver
Measured: 1 year
Secondary outcomes (1)
Compare presence and extent of the cholate clearances
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study start23 Jun 2011
- Primary completion19 May 2020
- Study completion20 May 2025
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Trotter, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907074
- Sponsor's protocol ID
- 011-063
- Status last verified
- Jan 2026
- First submitted
- 22 Jul 2013
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Liver Function Tests Using Cholates
- ClinicalTrials.gov ID
- NCT01907074
- Acronym / sponsor ID
- 011-063
- Conditions
- End Stage Liver Disease
- Keywords
- liver function tests, end stage liver disease, cirrhosis, living liver donor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 23 Jun 2011 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for their outcomes. The traditional assessment of the liver patient has been limited to imaging, static measures of "liver function tests" and liver biopsy. This protocol is designed to increase the spectrum of tests in the evaluation of the patient with end stage liver disease.
Detailed description
This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2
This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient [HVPG] procedure.)
The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholates Compound | Experimental | Drug: Cholates |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease patients
- Age: 18 yr to 80 yr
- Patients or Legal Authorized Representative (LAR) must provide written consent and be willing and able to adhere to study requirements
- Stage 3-4 fibrosis by METAVIR score or clinical evidence of advanced fibrosis (End-stage liver disease patients only)
Key exclusion criteria (5 listed)
- Hepatic encephalopathy Grade 3 or 4
- Pregnancy or intent to become pregnant
- Subjects with inability to provide consent for one's self
- Subjects with a life expectancy < 1 year
- Subjects who have participated in an investigational drug study within the past 30 days
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 |
|---|---|---|
| CholatesCholates is given intravenously (IV push) and by mouth, once per study visit | Drug | Cholates Compound |
Primary outcome
To determine the effectiveness and accuracy of quantitative liver function testing using oral and IV cholate in patients with end-stage liver disease OR in patients who donate a portion of their liver
Time frame: 1 year
1 secondary outcome
Compare presence and extent of the cholate clearances
Time frame: One year
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
James Trotter, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholates in people with End Stage Liver Disease, run by Baylor Research Institute at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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 was stopped early (reason given: PI left institution). 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?
To determine the effectiveness and accuracy of quantitative liver function testing using oral and IV cholate in patients with end-stage liver disease OR in patients who donate a portion of their liver (time frame: 1 year). 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 12 Feb 2026.