Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Neurology, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/23/2018 |
| Start Date: | November 2013 |
| End Date: | January 2017 |
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)
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.
from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
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)
OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated
Hyperammonemia with an Episode of Hepatic Encephalopathy (STOP-HE Study)
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
We found this trial at
46
sites
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