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