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Amino Acid Derivative

Ornithine phenylacetate for Hepatic Encephalopathy (STOP-HE Trial)

Phase 2
Waitlist Available
Research Sponsored by Mallinckrodt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study day 19

Summary

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

Eligible Conditions
  • Hepatic Encephalopathy
  • Encephalopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study day 19
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study day 19 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants in Each HE Stage
Secondary study objectives
Change from Baseline in Modified Orientation Log
Length of hospital stay
Other study objectives
Change from Baseline in Glasgow Coma Scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ornithine phenylacetateActive Control1 Intervention
Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
Group II: PlaceboPlacebo Group1 Intervention
Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC

Find a Location

Who is running the clinical trial?

MallinckrodtLead Sponsor
201 Previous Clinical Trials
15,635 Total Patients Enrolled
2 Trials studying Hepatic Encephalopathy
50 Patients Enrolled for Hepatic Encephalopathy
Ocera Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
30 Total Patients Enrolled
Stan Bukofzer, M.D.Study ChairOcera Therapeutics, Inc.
~20 spots leftby Oct 2025
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