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



Status:Completed
Conditions:Infectious Disease, Neurology, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:8/23/2018
Start Date:November 2013
End Date:January 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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.

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)

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
We found this trial at
46
sites
Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Atlanta, Georgia
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, Maryland
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Clinical Trial Facility in Bethesda Maryland
Bethesda, Maryland
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, Massachusetts
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Clinical Trial Facility in Buffalo New York
Buffalo, New York
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Clinical Trial Facility in Chapel Hill North Carolina
Chapel Hill, North Carolina
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Clinical Trial Facility in Charleston South Carolina
Charleston, South Carolina 29412
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Columbia Missouri
Columbia, Missouri 65201
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Columbia, MO
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Clinical Trial Facility in Columbus Ohio
Columbus, Ohio 43214
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Columbus, OH
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Clinical Trial Facility in Coronado California
Coronado, California 92118
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Coronado, CA
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Glenview Illinois
Glenview, Illinois 60026
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Glenview, IL
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Iowa City Iowa
Iowa City, Iowa 52242
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Iowa City, IA
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Clinical Trial Facility in Iowa City Iowa
Iowa City, Iowa 52242
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Iowa City, IA
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Clinical Trial Facility in Jackson Mississippi
Jackson, Mississippi 39216
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Jackson, MS
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Clinical Trial Facility in Kingswood New South Wales
Kingswood, New South Wales 2747
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Kingswood,
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Little Rock, AR
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Los Angeles, CA
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Clinical Trial Facility in Minneapolis Minnesota
Minneapolis, Minnesota 55455
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Minneapolis, MN
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in New Haven Connecticut
New Haven, Connecticut
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New Haven, CT
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Clinical Trial Facility in New Orleans Louisiana
New Orleans, Louisiana
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New Orleans, LA
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Clinical Trial Facility in New Orleans Louisiana
New Orleans, Louisiana
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New Orleans, LA
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in New York New York
New York, New York 10032
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Clinical Trial Facility in Newark New Jersey
Newark, New Jersey
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Philadelphia, PA
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Clinical Trial Facility in Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
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Clinical Trial Facility in Richmond Virginia
Richmond, Virginia 23227
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Richmond, VA
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Clinical Trial Facility in San Francisco California
San Francisco, California
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Clinical Trial Facility in Seattle Washington
Seattle, Washington 98105
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Clinical Trial Facility in Seattle Washington
Seattle, Washington 98105
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