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    Clinical Trial Results:
    A randomised, double-blind study evaluating the safety, tolerability, and clinical outcome of Neoven compared to Vaminolact® in premature extreme low birth weight (ELBW) infants.

    Summary
    EudraCT number
    		 2009-012603-26
    Trial protocol
    		 BE   DE   FR  
    Global end of trial date
    16 Apr 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2019
    First version publication date
    09 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    005-NEOV-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fresenius Kabi Deutschland GmbH
    Sponsor organisation address
    Borkenberg 14, Oberursel, Germany, 61440
    Public contact
    Divisional Medical & Clinical Affairs Clinical Nutrition & Ketosteril, Fresenius Kabi Deutschland GmbH , trial-disclosure@fresenius-kabi.com
    Scientific contact
    Divisional Medical & Clinical Affairs Clinical Nutrition & Ketosteril, Fresenius Kabi Deutschland GmbH , trial-disclosure@fresenius-kabi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000042-PIP01-07
    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
    24 Feb 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this trial was to evaluate the safety, tolerability, protein accretion, amino acid plasma levels and clinical outcome of Neoven compared to Vaminolact in hospitalized premature extreme low birth weight infants. The hypothesis of this study is that Neoven is non-inferior compared to Vaminolact. Non-inferiority for the primary endpoints in this study was defined as the lack of a pre-defined difference in specific primary safety endpoints (azotemia, metabolic acidosis, hyperammonemia, hyperaminoacidemia and hyperglycemia) between the two treatment groups. The study presented here, 05-NEOV-003 and another similar study, 05-NEOV-002 (EudraCT number: 2009-012602-39), were prematurely terminated due to a very low recruitment rate. The data of both studies were analyzed together and described in one report. Due to the premature termination of the studies, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    Protection of trial subjects
    Subject protection was ensured by high medical and ethical standards in accordance with Declaration of Helsinki, Good Clinical Practice and applicable national and local laws and regulations. The signed informed consent was obtained from the legal representative of the patient prior to inclusion in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 2010
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Netherlands: 12
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    17
    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)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 12 patients were enrolled in study 05-NEOV-002 and 5 patients were enrolled in study 05-NEOV-003. Overall, 17 patients were enrolled in both studies in 3 centers, thereof 9 (52.9 %) patients in the Neoven group and 8 (47.1 %) patients in the Vaminolact group. The data of patients enrolled in both prematurely ended studies were analyzed together.

    Pre-assignment
    Screening details
    		 Following patients were enrolled: Study 05-NEOV-002: male and female very low birth weight (bw) infants with a bw of 800 g to 1500 g, gestational age of 25 to 31 weeks, and < 48 hours after birth Study 05-NEOV-003: male and female premature extreme low bw infants with a bw ≤ 1000 g, gestational age of ≤ 29 weeks, and < 48 hours after birth

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Study medication was provided as bulk products to the hospital pharmacy and/or to laboratory for masking due to the different strengths of products: Neoven has strength of 10 % and Vaminolact of 6.5 %. Neoven was diluted to a strength of 6.5 %. The responsible contractor provided a blinded final PN product which did not reveal any treatment allocation. Additional independent unblinded study monitors checked adherence to pre-defined working procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Neoven
    Arm description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 3 patients in study 05-NEOV-003. Participants received Neoven to provide amino acids (AA) in the frame of a complete parenteral nutrition
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neoven
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Neoven was infused over at least 20 hours per treatment day for a minimum of 5 days in Study 05-NEOV-002 or for a minimum of 6 days in Study 05-NEOV-003. If clinically needed, the treatment period lasted until patient’s discharge; the maximum duration of the treatment period was limited to 28 days. In study 05-NEOV-002, the dose was increased stepwise up to 2.0 to 3.0 g AA/kg body weight/day on Day 3 of treatment, and in study 05-NEOV-003 up to 2.5 to 4.0 g AA/kg body weight/day on Day 4 of treatment.

    Arm title
    		 Vaminolact
    Arm description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 2 patients in study 05-NEOV-003. Participants received Vaminolact to provide AA in the frame of a complete parenteral nutrition
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vaminolact
    Investigational medicinal product code
    Other name
    Vaminolac, Vamin Infant
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vaminolact was infused over at least 20 hours per treatment day for a minimum of 5 days in the study 05-NEOV-002 or for a minimum of 6 days in study 05-NEOV-003. If clinically needed, the treatment period lasted until patient’s discharge; the maximum duration of the treatment period was limited to 28 days. In Study 05-NEOV-002, the dose was increased stepwise up to 2.0 to 3.0 g AA/kg body weight/day on Day 3 of treatment, and in study 05-NEOV-003 up to 2.5 to 4.0 g AA/kg body weight/day on Day 4 of treatment.

    Number of subjects in period 1
    		Neoven Vaminolact
    Started
    9
    8
    Completed
    7
    8
    Not completed
    2
    0
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Neoven
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 3 patients in study 05-NEOV-003. Participants received Neoven to provide amino acids (AA) in the frame of a complete parenteral nutrition

    Reporting group title
    Vaminolact
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 2 patients in study 05-NEOV-003. Participants received Vaminolact to provide AA in the frame of a complete parenteral nutrition

    Reporting group values
    		 Neoven Vaminolact Total
    Number of subjects
    		 9 8 17
    Age categorical
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 9 8 17
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: hours
        arithmetic mean (standard deviation)
    		 38.89 ± 8.038 37.25 ± 13.709 -
    Gender categorical
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: Subjects
        Female
    		 2 5 7
        Male
    		 7 3 10
    Subject analysis sets

    Subject analysis set title
    Safety Set Based on Joint Study Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Where possible, the tables and listings were based on the joined populations of two studies: 05-NEOV-002 and 05-NEOV-003 (joint study population). The only analysis population was the Safety Set, which was defined as all patients who were treated with study medication, regardless how much and when they received study treatment. The patient description and the analysis of safety and efficacy was performed for this population.

    Subject analysis sets values
    		 Safety Set Based on Joint Study Population
    Number of subjects
    17
    Age categorical
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    17
        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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: hours
        arithmetic mean (standard deviation)
    38.12 ± 10.735
    Gender categorical
    Patients from two studies: 05-NEOV-002 and 05-NEOV-003
    Units: Subjects
        Female
    7
        Male
    10

    End points

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    End points reporting groups
    Reporting group title
    Neoven
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 3 patients in study 05-NEOV-003. Participants received Neoven to provide amino acids (AA) in the frame of a complete parenteral nutrition

    Reporting group title
    Vaminolact
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 2 patients in study 05-NEOV-003. Participants received Vaminolact to provide AA in the frame of a complete parenteral nutrition

    Subject analysis set title
    Safety Set Based on Joint Study Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Where possible, the tables and listings were based on the joined populations of two studies: 05-NEOV-002 and 05-NEOV-003 (joint study population). The only analysis population was the Safety Set, which was defined as all patients who were treated with study medication, regardless how much and when they received study treatment. The patient description and the analysis of safety and efficacy was performed for this population.

    Primary: Occurrence of hyperammonaemia

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    End point title
    		 Occurrence of hyperammonaemia [1]
    End point description
    The primary variables were seen as safety parameters. The assessment of hyperammonaemia was based on the ammonia measurements.
    End point type
    Primary
    End point timeframe
    The assessment of hyperammonaemia was based on the ammonia measurements, which were planned on Study Day 3 in Study 05-NEOV-002 and on Study Day 4 or Study Day 5 in Study 05-NEOV-003.
    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: Due to the premature termination of the study, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    End point values
    		 Neoven Vaminolact Safety Set Based on Joint Study Population
    Number of subjects analysed
    9 [2]
    8 [3]
    17 [4]
    Units: Number of Subjects with at Least 1 Event
    1
    0
    1
    Notes
    [2] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [3] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [4] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    No statistical analyses for this end point

    Primary: Occurrence of metabolic acidosis

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    End point title
    		 Occurrence of metabolic acidosis [5]
    End point description
    The primary variables were seen as safety parameters. Metabolic acidosis was assessed from pH
    End point type
    Primary
    End point timeframe
    05-NEOV-002: On Study Day (D) 3, D5 & on D of last infusion. 05-NEOV-003: once between D6 & 8 and on D of last infusion. Also on D8, 11 or 12, 15 & 22 in 05-NEOV-002 and once between D13 & 15 in 05-NEOV-003 if patient continued to receive study drugs
    Notes
    [5] - 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: Due to the premature termination of the study, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    End point values
    		 Neoven Vaminolact Safety Set Based on Joint Study Population
    Number of subjects analysed
    9 [6]
    8 [7]
    17 [8]
    Units: Number of Subjects with at Least 1 Event
    4
    1
    5
    Notes
    [6] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [7] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [8] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    No statistical analyses for this end point

    Primary: Occurrence of azotaemia

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    End point title
    		 Occurrence of azotaemia [9]
    End point description
    The primary variables were seen as safety parameters. Azotaemia was assessed from blood urea nitrogen
    End point type
    Primary
    End point timeframe
    05-NEOV-002: On Study Day (D) 3, D5 & on D of last infusion. 05-NEOV-003: once between D6 & 8 and on D of last infusion. Also on D8, 11 or 12, 15 & 22 in 05-NEOV-002 and once between D13 & 15 in 05-NEOV-003 if patient continued to receive study drugs
    Notes
    [9] - 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: Due to the premature termination of the study, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    End point values
    		 Neoven Vaminolact Safety Set Based on Joint Study Population
    Number of subjects analysed
    9 [10]
    8 [11]
    17 [12]
    Units: Number of Subjects with at Least 1 Event
    1
    0
    1
    Notes
    [10] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [11] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [12] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    No statistical analyses for this end point

    Primary: Occurrence of hyperaminoacidaemia

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    End point title
    		 Occurrence of hyperaminoacidaemia [13]
    End point description
    The primary variables were seen as safety parameters. Hyperaminoacidaemia was assessed based on measurements of AAs
    End point type
    Primary
    End point timeframe
    The measurements of amino acids, by means of which hyperaminoacidaemia was assessed, were performed on Day 5 and on the day last study infusion stopped in 05-NEOV-002, and on Day 5 or Day 6 and on the day last study infusion stopped in 05-NEOV-003
    Notes
    [13] - 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: Due to the premature termination of the study, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    End point values
    		 Neoven Vaminolact Safety Set Based on Joint Study Population
    Number of subjects analysed
    6 [14]
    7 [15]
    13 [16]
    Units: Number of Subjects with at Least 1 Event
    0
    0
    0
    Notes
    [14] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [15] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [16] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    No statistical analyses for this end point

    Primary: Occurrence of hyperglycaemia

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    End point title
    		 Occurrence of hyperglycaemia [17]
    End point description
    The primary variables were seen as safety parameters. Hyperglycaemia was assessed based on measurements of blood glucose.
    End point type
    Primary
    End point timeframe
    05-NEOV-002: On Study Day (D) 3, D5 & on D of last infusion. 05-NEOV-003: once between D6 & 8 and on D of last infusion. Also on D8, 11 or 12, 15 & 22 in 05-NEOV-002 and once between D13 & 15 in 05-NEOV-003 if patient continued to receive study drugs
    Notes
    [17] - 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: Due to the premature termination of the study, it was decided to produce an abridged statistical evaluation only. All planned inference statistics were dropped.
    End point values
    		 Neoven Vaminolact Safety Set Based on Joint Study Population
    Number of subjects analysed
    9 [18]
    8 [19]
    17 [20]
    Units: Number of Subjects with at Least 1 Event
    1
    0
    1
    Notes
    [18] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [19] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    [20] - Safety Set Based on Joint Study Population (05-NEOV-002 and 05-NEOV-003). Post-baseline events
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From receipt of informed consent until the end of 1st period of investigations (28 days after last treatment with study drugs) in 05-NEOV-002 and until the end of follow-up (4- 6 weeks after last treatment with study drugs) in 05-NEOV-003
    Adverse event reporting additional description
    05-NEOV-002: Reporting period for serious AEs (SAEs) started from receipt of informed consent until the end of 2nd period of investigations (up to the age of 2 years life-corrected age) All SAEs and all treatment-emergent AEs (treatment period + follow-up period), occurred in the studies, are listed below.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Neoven
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 3 patients in study 05-NEOV-003. Participants received Neoven to provide AA in the frame of a complete parenteral nutrition

    Reporting group title
    Vaminolact
    Reporting group description
    		 This arm includes patients from both studies: 05-NEOV-002 and 05-NEOV-003. Of these, 6 patients were enrolled in Study 05-NEOV-002 and 2 patients in study 05-NEOV-003. Participants received Vaminolact to provide AA in the frame of a complete parenteral nutrition

    Serious adverse events
    		 Neoven Vaminolact
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 8 (50.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Necrotising colitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal infection
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Neoven Vaminolact
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    8 / 8 (100.00%)
    Vascular disorders
    Hypertension
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 8 (37.50%)
         occurrences all number
    2
    3
    Hypotension
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Discomfort
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Oedema peripheral
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary dysplasia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Investigations
    Blood calcium increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 8 (62.50%)
         occurrences all number
    2
    5
    Blood urea increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    4 / 9 (44.44%)
    3 / 8 (37.50%)
         occurrences all number
    4
    3
    Alanine aminotransferase decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 8 (50.00%)
         occurrences all number
    1
    4
    Aspartate aminotransferase decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 8 (37.50%)
         occurrences all number
    2
    4
    Base excess increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 8 (37.50%)
         occurrences all number
    1
    3
    Blood albumin increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Blood phosphorus decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 8 (25.00%)
         occurrences all number
    1
    3
    Mean arterial pressure increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Platelet count increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    3
    Blood bicarbonate increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Blood triglycerides increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Gamma-glutamyltransferase increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Haemoglobin decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Ammonia increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Bilirubin conjugated increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood chloride increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Body temperature decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Body temperature increased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Haematocrit decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Oxygen saturation decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Protein total decreased
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Congenital choroid plexus cyst
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Patent ductus arteriosus
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Bradycardia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Tachycardia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    4 / 9 (44.44%)
    1 / 8 (12.50%)
         occurrences all number
    5
    1
    Anaemia neonatal
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Thrombocytopenia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    3
    2
    Impaired gastric emptying
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vomiting
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 8 (62.50%)
         occurrences all number
    1
    5
    Cholestasis
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Azotaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Staphylococcal infection
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Device related infection
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Staphylococcal sepsis
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis bacterial
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Neonatal infection
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Staphylococcal skin infection
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Metabolic acidosis
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    4 / 9 (44.44%)
    1 / 8 (12.50%)
         occurrences all number
    5
    1
    Feeding disorder
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Hyponatraemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Hypercalcaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Hyperglycaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Hypocalcaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Hypoproteinaemia
    Additional description: Treatment-emergent AE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2010
    Relevant reasons for amendment: - Correction of some errors in exclusion criteria, more detailed description of some exclusion criteria - Correction of reference ranges for haematocrit and haemoglobin - Correction of blood sampling procedure - Removal of interim analysis statement - Clarified description of random and patient number allocation included - Corrected description of medical monitoring process - Clarification of laboratory data documentation to prevent unblinding - Clarification of withdrawal procedure - The optional N-balance will be done at Day 6 instead of day of enrolment - Correction of study drug label description - Clarification that unused study drug and material has to be returned to sponsor - Clarification that adverse event reporting period starts after first study-related procedure - Addition of a physical examination at Day Last Study Infusion Stops - Clarification of AE reporting procedure

    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.
    Premature termination of studies 05-NEOV-002 and 05-NEOV-003 due to a very low recruitment rate. Data of both studies were analyzed together and described in one clinical study report. Abridged statistical evaluation only.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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