Quantitative Liver Function Tests Using Cholates

Stopped early · Phase 2

Conditions studied: End Stage Liver Disease

In brief

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.

Key facts

Study ID

NCT01907074

Run by

Baylor Research Institute

People needed

103

Starts

2011-06-23

Expected to finish

2025-05-20

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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