Cholates for Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen byJames Trotter, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Baylor Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

James Trotter, MD

Principal Investigator

Baylor Health Care System

Eligibility Criteria

This trial is for adults aged 18 to 80 with end-stage liver disease, living liver donors, or those with congenital heart disease. Participants must be able to give written consent and follow study rules. Only patients with severe fibrosis as shown by specific tests or clinical evidence can join.

Inclusion Criteria

My liver disease is in an advanced stage, indicated by severe scarring.

I am between 18 and 80 years old.

I have end-stage liver disease, am a living liver donor, or have congenital heart disease.

See 1 more

Treatment Details

Interventions

Cholates (Bile Acid Sequestrant)

Trial OverviewThe trial is testing new quantitative liver function tests using cholates. These tests aim to better evaluate the condition of patients with advanced liver disease and could help in managing their treatment and predicting outcomes more accurately.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Cholates CompoundExperimental Treatment1 Intervention