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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2013-005412-10
    Trial protocol
    		 EE   CZ   AT   HU   IT   DE   NL   BE   DK   BG  
    Global end of trial date
    29 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2020
    First version publication date
    22 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OCR002-HE209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01966419
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Acronym: STOP-HE
    Sponsors
    Sponsor organisation name
    Ocera Therapeutics, Inc.
    Sponsor organisation address
    1425 U.S. Route 206, Bedminster, NJ, United States, 07921
    Public contact
    Mallinckrodt Medical Information Call Center, Ocera Therapeutics, Inc., +1 800-556-3314 Ext. 5, clinicaltrials@mnk.com
    Scientific contact
    Mallinckrodt Medical Information Call Center, Ocera Therapeutics, Inc., +1 800-556-3314 Ext. 5, clinicaltrials@mnk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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. 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.
    Protection of trial subjects
    The investigator ensured that this study was conducted in accordance with the principles of the Declaration of Helsinki (as amended in Tokyo, Venice, Hong Kong, South Africa, and Edinburgh), International Council for Harmonisation guidelines, or with the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the study patient. Further, protection of trial participants was ensured by an Independent Data Monitoring Committee (IDMC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    United States: 128
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Israel: 22
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    231
    EEA total number of subjects
    66
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    160
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 231 participants were enrolled (randomized) into the trial at multiple (68) sites in 15 countries, including the United States, Australia and Europe.

    Pre-assignment
    Screening details
    		 Of all potential patients screened, 231 patients were randomized in a 1:1 ratio.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    While the study was double-blind (participant and investigator blinded), the care provider and outcomes assessor were also blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Patients receive matching placebo via continuous IV infusion for up to 5 days, in addition to standard of care (SOC)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Matching placebo
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo for continuous IV infusion that is visually identical to the experimental product

    Arm title
    		 OCR-002
    Arm description
    		 Patients receive ornithine phenylacetate by continuous IV infusion for up to 5 days in addition to SOC
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ornithine phenylacetate
    Investigational medicinal product code
    Other name
    OCR-002
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation

    Number of subjects in period 1
    		Placebo OCR-002
    Started
    115
    116
    Intention to Treat (ITT) Population
    115
    116
    Safety Population
    112
    114
    Completed
    74
    80
    Not completed
    41
    36
         Voluntary withdrawal by patient or representative
    8
    4
         Adverse event, non-fatal
    2
    3
         Death
    14
    8
         Investigator decision
    -
    1
         Patient had liver transplant
    7
    4
         Lost to follow-up
    2
    2
         Reason not specified
    7
    14
         Missing
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients receive matching placebo via continuous IV infusion for up to 5 days, in addition to standard of care (SOC)

    Reporting group title
    OCR-002
    Reporting group description
    		 Patients receive ornithine phenylacetate by continuous IV infusion for up to 5 days in addition to SOC

    Reporting group values
    		 Placebo OCR-002 Total
    Number of subjects
    		 115 116 231
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 81 79 160
        From 65-84 years
    		 34 37 71
    Age continuous
    The aggregate mean and standard deviation of patient age (in years) is reported for the Intent to Treat (ITT) population.
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 9.5 ) 50 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 44 81
        Male
    		 78 72 150

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients receive matching placebo via continuous IV infusion for up to 5 days, in addition to standard of care (SOC)

    Reporting group title
    OCR-002
    Reporting group description
    		 Patients receive ornithine phenylacetate by continuous IV infusion for up to 5 days in addition to SOC

    Primary: Percentage of Participants in each HE Stage

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    End point title
    		 Percentage of Participants in each HE Stage [1]
    End point description
    To support the primary endpoint of confirmed clinical response, the investigator rated patients twice daily to determine the percentage of patients in each HE stage on a 4-point scale (from 4=coma to 0/1=no disorientation), where a lower score is better. Percentages less than 1 are entered as 0 due to database constraints. Not all patients were assessed at all post-baseline time points.
    End point type
    Primary
    End point timeframe
    Baseline to End of Study (at 3 hours Post End-of-Infusion or Early Hospital Discharge or Early Termination)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were performed to arrive at these summary aggregate data values.
    End point values
    		 Placebo OCR-002
    Number of subjects analysed
    115 [2]
    116 [3]
    Units: percentage of patients
    number (not applicable)
        Baseline, Stage 4
    10
    5
        Baseline, Stage 3
    26
    34
        Baseline, Stage 2
    62
    59
        Baseline, Stage 0/1
    0
    0
        Baseline, Missing
    3
    2
        Day 1- 7 am, Stage 4
    0
    0
        Day 1- 7 am, Stage 3
    0
    3
        Day 1- 7 am, Stage 2
    2
    3
        Day 1- 7 am, Stage 0/1
    0
    0
        Day 1- 7 am, Missing
    0
    0
        Day 1- 5 pm, Stage 4
    0
    5
        Day 1- 5 pm, Stage 3
    7
    14
        Day 1- 5 pm, Stage 2
    32
    36
        Day 1- 5 pm, Stage 0/1
    0
    1
        Day 1- 5 pm, Missing
    0
    0
        Day 2- 7 am, Stage 4
    3
    4
        Day 2 - 7 am, Stage 3
    21
    15
        Day 2 - 7 am, Stage 2
    61
    69
        Day 2 - 7 am, Stage 0/1
    10
    10
        Day 2 - 7 am, Missing
    0
    0
        Day 2 - 5 pm, Stage 4
    3
    4
        Day 2 - 5 pm, Stage 3
    14
    9
        Day 2 - 5 pm, Stage 2
    57
    61
        Day 2 - 5 pm, Stage 0/1
    16
    16
        Day 2 - 5 pm, Missing
    0
    0
        Day 3 - 7 am, Stage 4
    3
    2
        Day 3 - 7 am, Stage 3
    15
    10
        Day 3 - 7 am, Stage 2
    50
    55
        Day 3 - 7 am, Stage 0/1
    21
    25
        Day 3 - 7 am, Missing
    0
    0
        Day 3 - 5 pm, Stage 4
    3
    3
        Day 3 - 5 pm, Stage 3
    7
    9
        Day 3 - 5 pm, Stage 2
    46
    45
        Day 3 - 5 pm, Stage 0/1
    20
    27
        Day 3 - 5 pm, Missing
    0
    0
        Day 4 - 7 am, Stage 4
    2
    0
        Day 4 - 7 am, Stage 3
    5
    9
        Day 4 - 7 am, Stage 2
    42
    40
        Day 4 - 7 am, Stage 0/1
    28
    30
        Day 4 - 7 am, Missing
    0
    0
        Day 4 - 5 pm, Stage 4
    2
    0
        Day 4 - 5 pm, Stage 3
    7
    7
        Day 4 - 5 pm, Stage 2
    29
    34
        Day 4 - 5 pm, Stage 0/1
    25
    28
        Day 4 - 5 pm, Missing
    0
    0
        Day 5 - 7 am, Stage 4
    0
    0
        Day 5 - 7 am, Stage 3
    9
    7
        Day 5 - 7 am, Stage 2
    29
    28
        Day 5 - 7 am, Stage 0/1
    23
    32
        Day 5 - 7 am, Missing
    0
    0
        Day 5 - 5 pm, Stage 4
    0
    0
        Day 5 - 5 pm, Stage 3
    8
    3
        Day 5 - 5 pm, Stage 2
    24
    22
        Day 5 - 5 pm, Stage 0/1
    23
    28
        Day 5 - 5 pm, Missing
    0
    0
        Day 6 - 7 am, Stage 4
    0
    0
        Day 6 - 7 am, Stage 3
    10
    3
        Day 6 - 7 am, Stage 2
    21
    24
        Day 6 - 7 am, Stage 0/1
    23
    27
        Day 6 - 7 am, Missing
    0
    0
        Day 6 - 5 pm, Stage 4
    0
    0
        Day 6 - 5 pm, Stage 3
    3
    3
        Day 6 - 5 pm, Stage 2
    5
    7
        Day 6 - 5 pm, Stage 0/1
    6
    5
        Day 6 - 5 pm, Missing
    0
    0
        End of Study, Stage 4
    5
    3
        End of Study, Stage 3
    10
    7
        End of Study, Stage 2
    31
    28
        End of Study, Stage 0/1
    45
    55
        End of Study, Missing
    0
    0
    Notes
    [2] - ITT patients with data at the given time point - patients did not all start at the same time
    [3] - ITT patients with data at the given time point - patients did not all start at the same time
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 days
    Adverse event reporting additional description
    Adverse events are reported in the safety population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo up to 5 days continuous IV infusion in addition to standard of care (SOC)

    Reporting group title
    OCR-002
    Reporting group description
    		 Continuous intravenous infusion of ornithine phenylacetate for up to 5 days on top of standard of care at dose levels predicated on level of hepatic decompensation

    Serious adverse events
    		 Placebo OCR-002
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 112 (30.36%)
    29 / 114 (25.44%)
         number of deaths (all causes)
    15
    11
         number of deaths resulting from adverse events
    15
    11
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    4 / 112 (3.57%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 4
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic haemorrhage
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic hydrothorax
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    2 / 112 (1.79%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    9 / 112 (8.04%)
    9 / 114 (7.89%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intracranial pressure increased
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised intraabdominal fluid collection
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Chronic hepatic failure
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    2 / 112 (1.79%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Hepatic function abnormal
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    3 / 112 (2.68%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 112 (0.89%)
    3 / 114 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 112 (1.79%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    Hypovolaemia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo OCR-002
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 112 (27.68%)
    30 / 114 (26.32%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 112 (7.14%)
    13 / 114 (11.40%)
         occurrences all number
    11
    14
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 112 (6.25%)
    6 / 114 (5.26%)
         occurrences all number
    7
    6
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 112 (3.57%)
    8 / 114 (7.02%)
         occurrences all number
    4
    8
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    8 / 112 (7.14%)
    9 / 114 (7.89%)
         occurrences all number
    10
    9
    Hypophosphataemia
         subjects affected / exposed
    9 / 112 (8.04%)
    5 / 114 (4.39%)
         occurrences all number
    9
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2014
    The protocol was updated to facilitate participation of countries outside of North America and to improve recruitment rates.
    19 Mar 2014
    The protocol was modified to optimize the dosing paradigm.
    24 Oct 2014
    The protocol was updated to improve recruitment rate.
    01 Jul 2015
    The protocol was updated to incorporate recommendations from the Independent Data Monitoring Committee (IDMC).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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