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.

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.

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

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

While the study was double-blind (participant and investigator blinded), the care provider and outcomes assessor were also blinded.