Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
STOP-HE
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)
2 other identifiers
interventional
231
15 countries
127
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Typical duration for phase_2
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedStudy Start
First participant enrolled
January 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2016
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedSeptember 16, 2021
August 1, 2021
3 years
October 11, 2013
July 22, 2021
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Each HE Stage
To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse. The stages are described as: Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma)
Baseline to End of Study (through 3 hours post end-of-infusion)
Study Arms (2)
Ornithine phenylacetate
ACTIVE COMPARATORParticipants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
Placebo
PLACEBO COMPARATORParticipants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
Interventions
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
Placebo for continuous IV infusion that is visually identical to the experimental product
Eligibility Criteria
You may qualify if:
- Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
- Elevated venous ammonia
You may not qualify if:
- Renal failure with serum creatinine \> 3 mg/dL or need for dialysis
- Molecular Adsorbent Recirculation System utilized
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (131)
Unknown Facility
Phoenix, Arizona, 85006, 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, 90033, United States
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Los Angeles, California, 90048, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94143, United States
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New Haven, Connecticut, 06504, United States
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Miami, Florida, 33136, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Glenview, Illinois, 60026, United States
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Iowa City, Iowa, 52242, United States
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Iowa City, Iowa, 52246, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70121, United States
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Baltimore, Maryland, 21201, 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, 02114, 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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New York, New York, 10029, 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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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19141, 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, 75203, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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Richmond, Virginia, 23249, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98195, United States
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Milwaukee, Wisconsin, 53226, United States
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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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Melbourne, Victoria, 3004, 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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Vienna, 1160, Austria
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Brussels, 1020, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Brno, 625 00, Czechia
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Prague, 14021, Czechia
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Ústí nad Labem, 401 13, Czechia
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Aarhus, 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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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 im Breisgau, 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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Kaposvár, 7400, Hungary
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Pécs, 7624, Hungary
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Haifa, 3109601, Israel
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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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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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Florence, 50134, Italy
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Milan, 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, 111123, Russia
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Moscow, 117198, Russia
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Moscow, 119992, Russia
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Moscow, 129090, Russia
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Samara, 443011, Russia
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A Coruña, 15706, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Girona, 17007, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28222, Spain
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Málaga, 29010, Spain
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Pontevedra, 36071, Spain
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Santander, 39008, Spain
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Seville, 41014, Spain
Unknown Facility
Valencia, 46026, Spain
Related Publications (3)
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.
PMID: 35238476DERIVEDWang 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.
PMID: 34786649DERIVEDRahimi 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.
PMID: 33069881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY CHAIR
Clinical Team Leader
Ocera Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- While the study was double-blind (participant and investigator blinded), the care provider and outcomes assessor were also blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2013
First Posted
October 21, 2013
Study Start
January 7, 2014
Primary Completion
December 29, 2016
Study Completion
December 29, 2016
Last Updated
September 16, 2021
Results First Posted
September 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.