Clinical Trial: Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hypera
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 Summary: This is a multicenter, randomized, double-blind, placebo-controlled study of ornithine phenylacetate (OCR-002) administered intravenously to hospitalized patients with cirrhosis, hyperammonemia, and an acute episode of hepatic encephalopathy administered on top of standard of care treatment.
Sponsor: Ocera Therapeutics
Current Primary Outcome: Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ]
- Length of hospital stay [ Time Frame: Up to Study Day 19 ]
Original Secondary Outcome: Same as current
Information By: Ocera Therapeutics
Dates:
Date Received: October 11, 2013
Date Started: November 2013
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017
