Phase 2 N=231 Randomized Double-blind Treatment

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

Acute Episode of Overt Hepatic Encephalopathy · Hepatic Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT01966419 ↗

Enrolled (actual)

231

Serious AEs

27.9%

Results posted

Sep 2021

Primary outcome: Primary: Percentage of Participants in Each HE Stage — 11; 6; 30; 40 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ornithine phenylacetate (Drug); placebo intravenous infusion (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ocera Therapeutics, Inc.
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants in Each HE Stage	11; 6; 30; 40; 71; 68	—

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.

Eligibility Criteria

Inclusion Criteria

Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
Elevated venous ammonia

Exclusion Criteria

Renal failure with serum creatinine > 3 mg/dL or need for dialysis
Molecular Adsorbent Recirculation System utilized
Pregnancy or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01966419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.