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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
Placebo for continuous IV infusion that is visually identical to the experimental product
Percentage of Participants in Each HE Stage
To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse. The stages are described as: Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma)
Time frame: Baseline to End of Study (through 3 hours post end-of-infusion)
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Coronado, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Miami, Florida, United States
...and 121 more locations