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 : August 21, 2018
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:
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)

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 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)
Study Start Date : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Active Comparator: 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 ]
    HE Staging Tool to be completed by physician

Secondary Outcome Measures :
  1. Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ]
    MOL completed by physician

  2. Length of hospital stay [ Time Frame: Up to Study Day 19 ]
    Dates entered by site on CRF

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

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

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United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85054
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Coronado, California, United States, 92118
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90048
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Miami, Florida, United States, 33136
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Atlanta, Georgia, United States, 30309
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New Orleans, Louisiana, United States, 70112
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Baltimore, Maryland, United States, 21201
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Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
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Minneapolis, Minnesota, United States, 55455
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Jackson, Mississippi, United States, 39216
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Columbia, Missouri, United States, 65212
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Newark, New Jersey, United States, 07103
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Buffalo, New York, United States, 14215
New York, New York, United States, 10029
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Chapel Hill, North Carolina, United States, 27514
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Columbus, Ohio, United States, 43210
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Philadelphia, Pennsylvania, United States, 19104
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Milwaukee, Wisconsin, United States, 53226
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Melbourne, Victoria, Australia, 3004
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Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Leuven, Belgium, 3000
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Sofia, Bulgaria, 1606
Brno, Czechia, 625 00
Praha, Czechia, 14021
Usti nad Labem, Czechia, 401 13
Arhus, Denmark, 8000
Copenhagen, Denmark, 2100
Esbjerg, Denmark, 6700
Hvidovre, Denmark, 2650
Kobenhavn, Denmark, 2100
Tartu, Estonia, 51014
Bordeaux, France, 33000
Grenoble, France, 38043
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Lille, France, 59037
Lyon, France, 69317
Nice, France, 06200
Paris, France, 75651
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Toulouse, France, 31053
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Gyula, Hungary, 5700
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Jerusalem, Israel, 9112001
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Moscow, Russian Federation, 111123
Moscow, Russian Federation, 117198
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 129090
Samara, Russian Federation, 443011
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Girona, Spain, 17007
La Coruña, Spain, 15706
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28222
Malaga, Spain, 29010
Pontevedra, Spain, 36071
Santander, Spain, 39008
Sevilla, Spain, 41014
Valencia, Spain, 46026
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: August 21, 2018
Last Verified: March 2018

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