Overview

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

Status:
Completed
Trial end date:
2016-12-29
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ocera Therapeutics
Ocera Therapeutics, Inc.
Treatments:
Phenylacetic acid
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