STOP-HE

Protocol: 
OCR002-HE209
Phase: 
II

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)

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.

Trial Website: https://clinicaltrials.gov/show/NCT01966419

Are you Eligible? (Inclusion 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

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States