Hepatic Encephalopathy Clinical Trial
— STOP-HEOfficial title:
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)
Verified date | August 2021 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 231 |
Est. completion date | December 29, 2016 |
Est. primary completion date | December 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ocera Therapeutics, Inc. |
United States, Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Russian Federation, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants in Each HE Stage | To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse.
The stages are described as: Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma) |
Baseline to End of Study (through 3 hours post end-of-infusion) |
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