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

Last updated: August 19, 2021
Sponsor: Ocera Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Arginase Deficiency

Hyperargininemia

Hepatic Encephalopathy

Treatment

N/A

Clinical Study ID

NCT01966419
OCR002-HE209
2013-005412-10
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hospitalized with an acute episode of hepatic encephalopathy as complication ofcirrhosis
  • Elevated venous ammonia

Exclusion

Exclusion Criteria:

  • Renal failure with serum creatinine > 3 mg/dL or need for dialysis
  • Molecular Adsorbent Recirculation System utilized
  • Pregnancy or breastfeeding

Study Design

Total Participants: 231
Study Start date:
January 07, 2014
Estimated Completion Date:
December 29, 2016

Study Description

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.

Connect with a study center

  • Kingswood, New South Wales 2747
    Australia

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  • Adelaide, South Australia 5000
    Australia

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  • Bedford Park, South Australia 5042
    Australia

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    Fitzroy Victoria, 3065
    Australia

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  • Melbourne, 3065
    Australia

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  • Parkville, 3050
    Australia

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  • Graz, 8036
    Austria

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  • Vienna, 1090
    Austria

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  • Wien, 1160
    Austria

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  • Bruxelles, 1200
    Belgium

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  • Gent, 9000
    Belgium

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  • Leuven, 3000
    Belgium

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  • Sofia, 1606
    Bulgaria

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    Edmonton, Alberta T6G 2B7
    Canada

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  • Brno, 625 00
    Czechia

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  • Praha, 14021
    Czechia

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  • Usti nad Labem, 401 13
    Czechia

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  • Arhus, 8000
    Denmark

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  • Copenhagen, 2100
    Denmark

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  • Esbjerg, 6700
    Denmark

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  • Hvidovre, 2650
    Denmark

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  • Kobenhavn, 2100
    Denmark

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  • Tartu, 51014
    Estonia

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  • Bordeaux, 33000
    France

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  • Grenoble, 38043
    France

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  • La Roche, 85925
    France

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  • Lille, 59037
    France

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  • Lyon, 69317
    France

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  • Nice, 06200
    France

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  • Paris, 75651
    France

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  • Pessac, 33604
    France

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  • Toulouse, 31053
    France

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  • Villejuif, 94800
    France

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  • Hanover, Niedersachesen D-30625
    Germany

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  • Bonn, 53127
    Germany

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  • Freiburg, 79106
    Germany

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  • Halle, 06120
    Germany

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  • Hamburg, 20246
    Germany

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  • Heidelberg, 69120
    Germany

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  • Leipzig, 04103
    Germany

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  • Mainz, 55131
    Germany

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  • Debrecen, 4031
    Hungary

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  • Gyula, 5700
    Hungary

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  • Kaposvar, 7400
    Hungary

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  • Pecs, 7624
    Hungary

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  • Haifa, 3436212
    Israel

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  • Jerusalem, 9112001
    Israel

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  • Petah-Tikva, 49372
    Israel

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    Raman-Gat, 49372
    Israel

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  • Ramat-Gan, 49372
    Israel

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  • Safed, 13100
    Israel

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  • Tel Aviv, 64239
    Israel

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  • Bergamo, 24127
    Italy

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  • Bologna, 40138
    Italy

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  • Firenze, 50134
    Italy

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  • Milano, 20122
    Italy

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  • Palermo, 90141
    Italy

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  • Roma, 00161
    Italy

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  • Rozzano, 20089
    Italy

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  • San Giovanni Rotondo, 71013
    Italy

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  • Leiden, 2333 ZA
    Netherlands

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  • Maastricht, 6229 HX
    Netherlands

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  • Auckland, 1142
    New Zealand

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  • Moscow, 119992
    Russian Federation

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  • Samara, 443011
    Russian Federation

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  • Barcelona, 08041
    Spain

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    Cantabria, 39008
    Spain

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  • Girona, 17007
    Spain

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    La Caruna, 15706
    Spain

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  • La Coruña, 15706
    Spain

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    Le Coruna, 15706
    Spain

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  • Madrid, 28222
    Spain

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  • Malaga, 29010
    Spain

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  • Pontevedra, 36071
    Spain

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  • Santander, 39008
    Spain

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  • Sevilla, 41014
    Spain

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  • Valencia, 46026
    Spain

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    Birmingham, Alabama 35233
    United States

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  • Phoenix, Arizona 85054
    United States

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  • Little Rock, Arkansas 72205
    United States

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  • Coronado, California 92118
    United States

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  • Los Angeles, California 90048
    United States

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    Sacramento, California 95817
    United States

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  • San Francisco, California 94115
    United States

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  • New Haven, Connecticut 06504
    United States

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    Washington, District of Columbia 20007
    United States

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  • Miami, Florida 33136
    United States

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  • Atlanta, Georgia 30309
    United States

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  • Chicago, Illinois 60637
    United States

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  • Glenview, Illinois 60026
    United States

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    Indianapolis, Indiana 46202
    United States

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  • Iowa City, Iowa 52242
    United States

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  • New Orleans, Louisiana 70112
    United States

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  • Baltimore, Maryland 21287
    United States

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  • Bethesda, Maryland 20814
    United States

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  • Boston, Massachusetts 02215
    United States

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  • Minneapolis, Minnesota 55455
    United States

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  • Jackson, Mississippi 39216
    United States

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  • Columbia, Missouri 65212
    United States

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  • Newark, New Jersey 07103
    United States

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  • Buffalo, New York 14215
    United States

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    Mineola, New York 11501
    United States

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  • New York, New York 10032
    United States

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  • Chapel Hill, North Carolina 27514
    United States

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  • Columbus, Ohio 43210
    United States

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    Portland, Oregon 97239
    United States

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  • Philadelphia, Pennsylvania 19104
    United States

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  • Pittsburgh, Pennsylvania 15213
    United States

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  • Charleston, South Carolina 29425
    United States

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  • Nashville, Tennessee 37232
    United States

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  • Dallas, Texas 75390
    United States

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  • Houston, Texas 77030
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  • Richmond, Virginia 23249
    United States

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  • Seattle, Washington 98195
    United States

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  • Milwaukee, Wisconsin 53226
    United States

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