Clinical trial NCT01966419: Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Episode of Overt Hepatic Encephalopathy
Hepatic Encephalopathy
Keywords: hepatic encephalopathy
hyperammonemia
cirrhosis
ornithine phenylacetate
OCR-002
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
* Elevated venous ammonia

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants in Each HE Stage
timeFrame: Baseline to End of Study (through 3 hours post end-of-infusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Coronado
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Glenview
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Kingswood
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Bedford Park
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
city: Parkville
country: Australia
city: Graz
country: Austria
city: Vienna
country: Austria
city: Wien
country: Austria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Brno
country: Czechia
city: Praha
country: Czechia
city: Usti nad Labem
country: Czechia
city: Arhus
country: Denmark
city: Copenhagen
country: Denmark
city: Esbjerg
country: Denmark
city: Hvidovre
country: Denmark
city: Kobenhavn
country: Denmark
city: Tartu
country: Estonia
city: Bordeaux
country: France
city: Grenoble
country: France
city: La Roche
country: France
city: Lille
country: France
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Pessac
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Hanover
country: Germany
state: Niedersachesen
city: Bonn
country: Germany
city: Freiburg
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Pecs
country: Hungary
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah-Tikva
country: Israel
city: Ramat-Gan
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Auckland
country: New Zealand
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: La Coruña
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Pontevedra
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Ocera Therapeutics, Inc.
name: Clinical Team Leader
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.