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 range

18 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More End Stage Liver Disease trials