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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