VE303 for Treatment of Hepatic Encephalopathy (HE)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cirrhosis
- Hepatic Encephalopathy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized 2:1 to VE303 vs placebo. There will be no stratification. After the trial enrolls the first 9 patients, an interim analysis to evaluate safety of VE303 in this population will take place. If there is no concern for a higher rate of Serious adverse events (SAEs) in the VE303 group, enrollment will continue to reach a total of 18 patients.Masking: Double (Participant, Investigator)Masking Description: Study staff will remain blinded to subject randomization until the study period is over.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04899115
- Collaborators
- Vedanta Biosciences, Inc.
- American College of Gastroenterology
- American Association for the Study of Liver Diseases
- Investigators
- Principal Investigator: Patricia Bloom, MD University of Michigan
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