Status:
ACTIVE_NOT_RECRUITING
Quantitative Liver Function Tests Using Cholates
Lead Sponsor:
Baylor Research Institute
Conditions:
End Stage Liver Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 nee...
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 intraveno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01907074
Start Date
July 1 2011
End Date
December 1 2025
Last Update
January 30 2024
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246