Status:
COMPLETED
VE303 for Treatment of Hepatic Encephalopathy (HE)
Lead Sponsor:
Patricia Bloom
Collaborating Sponsors:
Vedanta Biosciences, Inc.
American College of Gastroenterology
Conditions:
Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy. Eligible participants will be enrolled and given oral antibiotics fol...
Eligibility Criteria
Inclusion
- Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation
- History of at least one episode of overt HE any time in the past
- Prescribed both lactulose and rifaximin, and compliant with this treatment
Exclusion
- Current episode of overt HE
- Variceal bleeding in the last 4 weeks
- Gut-absorbable or intravenous antibiotic therapy in the last 28 days
- Fecal microbiota transplant in the last 6 months
- Use of probiotics in the last 2 weeks
- Alcohol or illicit drug intake in the last 4 weeks
- Primary sclerosing cholangitis as etiology of liver disease
- History of inflammatory bowel disease, short gut, gastrointestinal tract fistulas, intestinal ischemia, or any form of ongoing colitis
- Prior diagnosis of dementia or other primary neurocognitive disorder
- Known hypersensitivity/allergy/intolerance to Vancomycin and any ingredients of VE303: sucrose, histidine, yeast extract, cysteine, metabisulfite, and microcrystalline cellulose
- History of Roux-en-Y Gastric bypass
- Any gastrointestinal surgery in the last year
- Substantial immune compromise/deficiency (e.g., uncontrolled human immunodeficiency virus, active immune suppressive therapy including high doses of corticosteroids or medications to prevent graft rejection, recent myeloablative therapy, sustained neutropenia)
- Pregnancy or breast feeding
- Model for end-stage liver disease (MELD) \> 20
- History of spontaneous bacterial peritonitis
- Hemodialysis in the last 28 days
- Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment)
- Unstable doses of opiates, benzodiazepines or other sedating medication
- Chronic methadone or low dose benzodiazepines (for example) is acceptable
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04899115
Start Date
August 6 2021
End Date
August 30 2023
Last Update
February 7 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109