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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01966419
Registration number
NCT01966419
Ethics application status
Date submitted
11/10/2013
Date registered
21/10/2013
Date last updated
16/09/2021
Titles & IDs
Public title
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
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Scientific 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)
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Secondary ID [1]
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2013-005412-10
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Secondary ID [2]
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OCR002-HE209
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Universal Trial Number (UTN)
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Trial acronym
STOP-HE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Episode of Overt Hepatic Encephalopathy
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Hepatic Encephalopathy
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Neurological
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Other neurological disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ornithine phenylacetate
Treatment: Drugs - placebo intravenous infusion
Active Comparator: Ornithine phenylacetate - Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
Placebo Comparator: Placebo - Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
Treatment: Drugs: ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
Treatment: Drugs: placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants in Each HE Stage
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline to End of Study (through 3 hours post end-of-infusion)
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Eligibility
Key inclusion criteria
- Hospitalized with an acute episode of hepatic encephalopathy as complication of
cirrhosis
- Elevated venous ammonia
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Renal failure with serum creatinine > 3 mg/dL or need for dialysis
- Molecular Adsorbent Recirculation System utilized
- Pregnancy or breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/12/2016
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Sample size
Target
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Accrual to date
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Final
231
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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- Kingswood
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- Adelaide
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- Bedford Park
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- Melbourne
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- Parkville
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2747 - Kingswood
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5000 - Adelaide
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5042 - Bedford Park
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3004 - Melbourne
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3065 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Funding & Sponsors
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Name
Ocera Therapeutics, Inc.
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01966419
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Team Leader
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Ocera Therapeutics, Inc.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01966419
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