Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
NCT ID: NCT01966419
Last Updated: 2021-09-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2014-01-07
2016-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
NCT01548690
Emergency Use of OCR-002 in Acute Liver Failure (ALF)
NCT01634230
Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding
NCT01434108
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
NCT04128462
Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.
NCT01041755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ornithine phenylacetate
Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
Placebo
Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elevated venous ammonia
Exclusion Criteria
* Molecular Adsorbent Recirculation System utilized
* Pregnancy or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ocera Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Team Leader
Role: STUDY_CHAIR
Ocera Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Coronado, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Glenview, Illinois, United States
Iowa City, Iowa, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Columbia, Missouri, United States
Newark, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Kingswood, New South Wales, Australia
Adelaide, South Australia, Australia
Bedford Park, South Australia, Australia
Melbourne, Victoria, Australia
Melbourne, , Australia
Parkville, , Australia
Graz, , Austria
Vienna, , Austria
Vienna, , Austria
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Brno, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Aarhus, , Denmark
Copenhagen, , Denmark
Esbjerg, , Denmark
Hvidovre, , Denmark
Tartu, , Estonia
Bordeaux, , France
Grenoble, , France
La Roche, , France
Lille, , France
Lyon, , France
Nice, , France
Paris, , France
Pessac, , France
Toulouse, , France
Villejuif, , France
Hanover, Niedersachesen, Germany
Bonn, , Germany
Freiburg im Breisgau, , Germany
Halle, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Leipzig, , Germany
Mainz, , Germany
Debrecen, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Pécs, , Hungary
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Safed, , Israel
Tel Aviv, , Israel
Bergamo, , Italy
Bologna, , Italy
Florence, , Italy
Milan, , Italy
Palermo, , Italy
Roma, , Italy
Rozzano, , Italy
San Giovanni Rotondo, , Italy
Leiden, , Netherlands
Maastricht, , Netherlands
Auckland, , New Zealand
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Samara, , Russia
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Pontevedra, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Safadi R, Rahimi RS, Thabut D, Bajaj JS, Ram Bhamidimarri K, Pyrsopoulos N, Potthoff A, Bukofzer S, Wang L, Jamil K, Devarakonda KR. Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes. Clin Transl Sci. 2022 Jun;15(6):1449-1459. doi: 10.1111/cts.13257. Epub 2022 Mar 3.
Wang X, Vilchez RA. Population Pharmacokinetic Analysis to Assist Dose Selection of the L-Ornithine Salt of Phenylacetic Acid. Clin Pharmacokinet. 2022 Apr;61(4):515-526. doi: 10.1007/s40262-021-01075-1. Epub 2021 Nov 17.
Rahimi RS, Safadi R, Thabut D, Bhamidimarri KR, Pyrsopoulos N, Potthoff A, Bukofzer S, Bajaj JS. Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2626-2635.e7. doi: 10.1016/j.cgh.2020.10.019. Epub 2020 Oct 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-005412-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OCR002-HE209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.