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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT01966419
First received: October 11, 2013
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Acute Episode of Overt Hepatic Encephalopathy Hepatic Encephalopathy Drug: ornithine phenylacetate Drug: placebo intravenous infusion Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ocera Therapeutics:

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

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

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

Enrollment: 231
Study Start Date: November 2013
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966419

  Hide Study Locations
Locations
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
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143
United States, Connecticut
New Haven, Connecticut, United States, 06504
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Glenview, Illinois, United States, 60026
United States, Iowa
Iowa City, Iowa, United States, 52242
Iowa City, Iowa, United States, 52246
United States, Louisiana
New Orleans, Louisiana, United States, 70112
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21287
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia, Missouri, United States, 65212
United States, New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Buffalo, New York, United States, 14215
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19141
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75203
Dallas, Texas, United States, 75235
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Seattle, Washington, United States, 98104
Seattle, Washington, United States, 98195
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Kingswood, New South Wales, Australia, 2747
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Melbourne, Victoria, Australia, 3004
Australia
Fitzroy Victoria, Australia, 3065
Parkville, Australia, 3050
Austria
Graz, Austria, 8036
Vienna, Austria, 1090
Wien, Austria, 1160
Belgium
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Leuven, Belgium, 3000
Bulgaria
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Czech Republic
Brno, Czech Republic, 625 00
Praha, Czech Republic, 14021
Usti nad Labem, Czech Republic, 401 13
Denmark
Arhus, Denmark, 8000
Copenhagen, Denmark, 2100
Esbjerg, Denmark, 6700
Hvidovre, Denmark, 2650
Kobenhavn, Denmark, 2100
Estonia
Tartu, Estonia, 51014
France
Bordeaux, France, 33000
Grenoble, France, 38043
La Roche, France, 85925
Lille, France, 59037
Lyon, France, 69317
Nice, France, 06200
Paris, France, 75651
Pessac, France, 33604
Toulouse, France, 31053
Villejuif, France, 94800
Germany
Hanover, Niedersachesen, Germany, D-30625
Bonn, Germany, 53127
Freiburg, Germany, 79106
Halle, Germany, 06120
Hamburg, Germany, 20246
Heidelberg, Germany, 69120
Leipzig, Germany, 04103
Mainz, Germany, 55131
Hungary
Debrecen, Hungary, 4031
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Pecs, Hungary, 7624
Israel
Haifa, Israel, 3109601
Haifa, Israel, 3436212
Jerusalem, Israel, 9112001
Petah-Tikva, Israel, 49372
Ramat-Gan, Israel, 49372
Safed, Israel, 13100
Tel Aviv, Israel, 64239
Italy
Bergamo, Italy, 24127
Bologna, Italy, 40138
Firenze, Italy, 50134
Milano, Italy, 20122
Palermo, Italy, 90141
Roma, Italy, 00161
Rozzano, Italy, 20089
San Giovanni Rotondo, Italy, 71013
Netherlands
Leiden, Netherlands, 2333 ZA
Maastricht, Netherlands, 6229 HX
New Zealand
Auckland, New Zealand, 1142
Russian Federation
Moscow, Russian Federation, 111123
Moscow, Russian Federation, 117198
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 129090
Samara, Russian Federation, 443011
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Cantabria, Spain, 39008
Girona, Spain, 17007
La Caruna, Spain, 15706
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28222
Malaga, Spain, 29010
Pontevedra, Spain, 36071
Sevilla, Spain, 41014
Valencia, Spain, 46026
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Study Chair: Stan Bukofzer, M.D. Ocera Therapeutics, Inc.
  More Information

Responsible Party: Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT01966419     History of Changes
Other Study ID Numbers: OCR002-HE209
Study First Received: October 11, 2013
Last Updated: February 16, 2017

Keywords provided by Ocera Therapeutics:
hepatic encephalopathy
hyperammonemia
cirrhosis
ornithine phenylacetate
OCR-002

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Hyperammonemia
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017