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

Phase 2

Completed

• Conditions: Hepatic Encephalopathy; Acute Episode of Overt Hepatic Encephalopathy
• Interventions: Drug: ornithine phenylacetate; Drug: placebo intravenous infusion

• Registration Number: NCT01966419
• Lead Sponsor: Ocera Therapeutics, Inc.

Brief 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.

Detailed Description

The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.

Study Timeline

• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Study Start: 2014-01-07
• Primary Completion: 2016-12-29
• Study Completion: 2016-12-29
• Disposition First Submitted: 2018-03-06
• Disposition First Submitted QC: 2018-08-16
• Disposition First Posted: 2018-08-21
• Results First Submitted: 2021-07-22
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Results First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ornithine phenylacetate	ornithine phenylacetate	Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
Placebo	placebo intravenous infusion	Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in Each HE Stage	Baseline to End of Study (through 3 hours post end-of-infusion)	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)