Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With 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.

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Key information

Conditions

Acute Episode of Overt Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Hyperammonemia Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingswood, New South Wales, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ornithine Phenylacetate

Drug

Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation

Other names: OCR-002

placebo intravenous infusion

Drug

Placebo for continuous IV infusion that is visually identical to the experimental product

Other names: Matching Placebo

Primary outcomes

Percentage of Participants in Each HE Stage

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ocera Therapeutics, Inc.

Industry

Registry information

Official study 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)

Acronym: STOP-HE

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 21, 2013
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed