Quantitative Liver Function Tests Using Cholates

NCT01907074 | Terminated Phase 2 DMC

• 1 other identifier: 011-063
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Liver Disease

Keywords

liver function tests; end stage liver disease; cirrhosis; living liver donor

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• Compare presence and extent of the cholate clearances

  One year

Other Outcomes (1)

• Annual tests to measure changes in liver function

  one year

Study Arms (1)

Cholates Compound

EXPERIMENTAL

Drug: Cholates

Interventions

Cholates DRUG

Cholates is given intravenously (IV push) and by mouth, once per study visit

Cholates Compound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Fibrosis

Interventions

Cholates

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• James Trotter, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 24, 2013
• Study Start: June 23, 2011
• Primary Completion: May 19, 2020
• Study Completion: May 20, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)