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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01966419
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : February 20, 2017
Information provided by (Responsible Party):
Ocera Therapeutics

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.

Condition or disease Intervention/treatment Phase
Acute Episode of Overt Hepatic Encephalopathy Hepatic Encephalopathy Drug: ornithine phenylacetate Drug: placebo intravenous infusion Phase 2

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study of ornithine phenylacetate (OCR-002) administered intravenously to hospitalized patients with cirrhosis, hyperammonemia, and an acute episode of hepatic encephalopathy administered on top of standard of care treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study
Study Start Date : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: ornithine phenylacetate
continuous intravenous infusion of ornithine phenylacetate for up to 5 days on top of standard of care
Drug: ornithine phenylacetate
dose levels predicated on level of hepatic decompensation
Other Name: OCR-002

Placebo Comparator: placebo intravenous infusion
continuous intravenous infusion of placebo up to 5 days on top of standard of care
Drug: placebo intravenous infusion
visually identical to active experimental
Other Name: 5% dextrose in water

Primary Outcome Measures :
  1. Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ]

Secondary Outcome Measures :
  1. Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ]
  2. Length of hospital stay [ Time Frame: Up to Study Day 19 ]

Other Outcome Measures:
  1. Change from Baseline in Glasgow Coma Scale [ Time Frame: Up to Study Day 19 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01966419

  Show 132 Study Locations
Sponsors and Collaborators
Ocera Therapeutics
Study Chair: Stan Bukofzer, M.D. Ocera Therapeutics, Inc.

Responsible Party: Ocera Therapeutics Identifier: NCT01966419     History of Changes
Other Study ID Numbers: OCR002-HE209
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Keywords provided by Ocera Therapeutics:
hepatic encephalopathy
ornithine phenylacetate

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Pathologic Processes
Phenylacetic acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents