Completed
Phase 2
Age: 18Years - 75Years
All Genders
ID01966419
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 Study
Led by Ocera Therapeutics, Inc. · Updated on 2021-09-16
231
Participants Needed
131
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
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
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