NCT04899115

VE303 for Treatment of Hepatic Encephalopathy (HE)

A Randomized Controlled Trial of VE303 to Treat Hepatic Encephalopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Patricia Bloom · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study. The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.

Conditions

• Cirrhosis
• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Placebo	Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
DRUG	VE303	Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of VE303 taken daily for 14 days. The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
DRUG	oral vancomycin	All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).

Timeline

• Start date: 2021-08-06
• Primary completion: 2023-04-10
• Completion: 2023-08-30
• First posted: 2021-05-24
• Last updated: 2025-02-07
• Results posted: 2024-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study