At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 231 enrolled
Drug / intervention
ornithine phenylacetate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)
In Brief
A Phase 2 clinical trial evaluating ornithine phenylacetate and placebo intravenous infusion for Acute Episode of Overt Hepatic Encephalopathy and Hepatic Encephalopathy. Completed, enrolled 231 participants across 131 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Russia, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartJan 2014
Primary CompletionDec 2016
TodayJul 2026
First PostedOct 21, 2013
Enrollment StartJan 7, 2014
Primary CompletionDec 29, 2016
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.7 years ago
Interventions
ornithine phenylacetatedrug
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
placebo intravenous infusiondrug
Placebo for continuous IV infusion that is visually identical to the experimental product