Conditions: Acute Episode of Overt Hepatic Encephalopathy Hepatic Encephalopathy
Keywords: hepatic encephalopathy hyperammonemia cirrhosis ornithine phenylacetate OCR-002
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC) arm 2: Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC

Interventions: intervention 1: ornithine phenylacetate intervention 2: placebo intravenous infusion
Intervention descriptions: intervention 1: Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation intervention 2: Placebo for continuous IV infusion that is visually identical to the experimental product

Protocol document: