Clinical trial

Quantitative Liver Function Tests Using Cholates

NCT01907074

Name

011-063

Description

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.

Trial arms

Trial start

2011-07-01

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Cholates

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

Arms:

Cholates Compound

Size

200

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

1 product

1 indication

Organization

Baylor Research Institute

Product

Cholates

Indication

End-Stage Liver Disease