Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
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.
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
- 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 6, 2014
- Primary completion
- Dec 28, 2016
- Completion
- Dec 28, 2016
- Last update posted
- Sep 15, 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 15, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01966419 live on ClinicalTrials.gov.