TerminatedPhase 2

Quantitative Liver Function Tests Using Cholates

Stopped: PI left institution

United States103 participantsStarted 2011-06-23

Plain-language 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 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT01907074

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-19