Quantitative Liver Function Tests Using Cholates

NCT ID: NCT01907074

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2

This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient [HVPG] procedure.)

The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic

Conditions

End Stage Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC

Study Groups

Cholates Compound

Group Type: EXPERIMENTAL

Cholates

Intervention Type: DRUG

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

Interventions

Cholates

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Trotter, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

011-063

Identifier Type: -

Identifier Source: org_study_id