TerminatedPhase 2
Quantitative Liver Function Tests Using Cholates
Key facts
- Who runs it
- Baylor Research Institute
- Where
- Dallas, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 103 people enrolled
- Started
- 23 Jun 2011
- Ended
- 20 May 2025
- Type of study
- Interventional
- Treatments tested
- Cholates
- Record updated
- 12 February 2026
- Why it stopped
- PI left institution
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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 take part
- Subjects who have participated in an investigational drug study within the past 30 days
- 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
Where in United States
- Baylor University Medical CenterDallas, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Cholates CompoundTreatment being tested
Treatment: Cholates
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 February 2026