Cholates for Liver Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor Research Institute

Disqualifiers: Hepatic encephalopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the drug cholates differ from other treatments for liver disease?

Cholates may offer a unique approach to treating liver disease by potentially improving liver function through mechanisms similar to those seen with phosphatidyl choline, which has been shown to aid in liver recovery and reduce liver damage in various studies. This could make cholates a novel option compared to standard treatments that may not specifically target these pathways. ^{1 2 3 4 5}

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

I am willing and able to follow the study requirements and have provided written consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the dual cholate test to assess liver function, including oral and intravenous cholate clearance and cholate shunt fraction measurement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cholate test

4 weeks

Treatment Details

Interventions

• Cholates

Trial Overview The 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

Group I: Cholates Compound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of polyunsaturated phosphatidyl choline in the treatment of acute viral hepatitis. [2019]

2. Nigeria pubmed.ncbi.nlm.nih.gov

The effects of essential phospholipid choline in HBs-Ag negative acute hepatitis. [2004]

3. Greece pubmed.ncbi.nlm.nih.gov

Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double-blind, placebo-controlled trial. Leich Study Group. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Plasma free choline is a novel non-invasive biomarker for early-stage non-alcoholic steatohepatitis: A multi-center validation study. [2020]

5. Ukraine pubmed.ncbi.nlm.nih.gov

[MОRPHOLOGICAL HEPATIC CHANGES IN RATS WHILE CCL(4) —ІNDUCED CIRRHOSIS AND HEPATIC ENCEPHALOPATHY ON BACKGROUND OF TREATMENT]. [2018]