CompletedPhase 2

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

United States231 participantsStarted 2014-01-07

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants in Each HE Stage

Timeframe: Baseline to End of Study (through 3 hours post end-of-infusion)

Trial details

NCT IDNCT01966419

SponsorOcera Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-29

Results submitted2021-07-22

View on ClinicalTrials.gov More Acute Episode of Overt Hepatic Encephalopathy trials