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Liver Disease/Hepatology Clinical Trials

A 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)
Aims: The purpose of this study is to evaluate the safety and efficacy of OCR-002 administered via continuous intravenous (IV) infusion to hospitalized patients with cirrhosis, hyperammonemia, and an acute episode of hepatic encephalopathy Stages 2-4. The primary endpoint is time to confirmed clinical response defined as a reduction to Stage 2 or  improvement to Stage 0/1. 
Diagnosis: Hepatic Encephalopathy
Principal Investigator
: Dhiren Shah, MD
Other Investigator:
Jonathan Williams, DO
IRB Approval Number: EH 14-183
Sponsor: Ocera Therapeutics
Contact:  Interested patients should contact study coordinator Boris Jancan, CCRP at 847.570.1583
Open to Enrollment:
Yes