NCT01966419

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Ocera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.

Conditions

• Acute Episode of Overt Hepatic Encephalopathy
• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	ornithine phenylacetate	Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
DRUG	placebo intravenous infusion	Placebo for continuous IV infusion that is visually identical to the experimental product

Timeline

• Start date: 2014-01-07
• Primary completion: 2016-12-29
• Completion: 2016-12-29
• First posted: 2013-10-21
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

131 sites across 17 countries: United States, Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Russia, Spain