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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01966419

Public ClinicalTrials.gov record NCT01966419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 7:46 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01966419
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Ocera Therapeutics, Inc.
Industry
Enrollment
231 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2014 (Actual)
Primary completion
Dec 29, 2016 (Actual)
Completion
Dec 29, 2016 (Actual)
Last update posted
Sep 16, 2021

2014 – 2016

United States locations

U.S. sites
49
U.S. states
25
U.S. cities
32
Facility City State ZIP Site status
Not listed Phoenix Arizona 85006 —
Not listed Phoenix Arizona 85054 —
Not listed Little Rock Arkansas 72205 —
Not listed Coronado California 92118 —
Not listed Los Angeles California 90033 —
Not listed Los Angeles California 90048 —
Not listed San Francisco California 94115 —
Not listed San Francisco California 94143 —
Not listed New Haven Connecticut 06504 —
Not listed Miami Florida 33136 —
Not listed Atlanta Georgia 30309 —
Not listed Atlanta Georgia 30322 —
Not listed Chicago Illinois 60611 —
Not listed Chicago Illinois 60612 —
Not listed Chicago Illinois 60637 —
Not listed Glenview Illinois 60026 —
Not listed Iowa City Iowa 52242 —
Not listed Iowa City Iowa 52246 —
Not listed New Orleans Louisiana 70112 —
Not listed New Orleans Louisiana 70121 —
Not listed Baltimore Maryland 21201 —
Not listed Baltimore Maryland 21287 —
Not listed Bethesda Maryland 20814 —
Not listed Boston Massachusetts 02114 —
Not listed Boston Massachusetts 02215 —
Not listed Minneapolis Minnesota 55455 —
Not listed Jackson Mississippi 39216 —
Not listed Columbia Missouri 65212 —
Not listed Newark New Jersey 07103 —
Not listed Buffalo New York 14215 —
Not listed New York New York 10029 —
Not listed New York New York 10032 —
Not listed Chapel Hill North Carolina 27514 —
Not listed Columbus Ohio 43210 —
Not listed Philadelphia Pennsylvania 19104 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Philadelphia Pennsylvania 19141 —
Not listed Pittsburgh Pennsylvania 15213 —
Not listed Charleston South Carolina 29425 —
Not listed Nashville Tennessee 37232 —
Not listed Dallas Texas 75203 —
Not listed Dallas Texas 75235 —
Not listed Dallas Texas 75246 —
Not listed Dallas Texas 75390 —
Not listed Houston Texas 77030 —
Not listed Richmond Virginia 23249 —
Not listed Seattle Washington 98104 —
Not listed Seattle Washington 98195 —
Not listed Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 82 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01966419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 16, 2021 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01966419 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →