Status:
COMPLETED
Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment
Lead Sponsor:
Georgetown University
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular carcinoma (HCC). Be...
Detailed Description
The purpose of this study is to measure blood levels of proglumide after a single oral dose (400 mg) over a period of time and compare the blood levels to those with normal hepatic function (N=4) to d...
Eligibility Criteria
Inclusion
- Cirrhosis previously confirmed by one of the following: Liver biopsy, FibroScan, FibroSure, MR-Elastography, or nodular liver on radiographic imaging like CT or MRI. Child-Pugh classification A (N=4) and Child-Pugh classification B (N=4)
Exclusion
- Those that are Child-Pugh classification C cirrhosis
- gastrointestinal bleeding from esophageal varices within 6 months
- Chronic kidney disease with Estimated glomerular filtration rate (eGFR of \< 90 mL/min/1.73m2)
- hepatic encephalopathy
- those that have had an organ transplant
- active hepatitis C, active hepatitis B, and those with HIV disease
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04814602
Start Date
March 30 2021
End Date
February 20 2022
Last Update
March 15 2022
Active Locations (1)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20007