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    Clinical Trial Results:
    Phase IV/II open label study for the early evaluation of the response to treatment with Cisplatin, Gemcitabine and Bevacizumab in patientes with advanced or metastatic non small cell lung cancer.

    Summary
    EudraCT number
    2012-000459-15
    Trial protocol
    ES  
    Global end of trial date
    13 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Nov 2021
    First version publication date
    17 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IMPACT
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per la Recerca Biomèdica
    Sponsor organisation address
    Calle Villarroel, 170 , Barcelona, Spain, 08036
    Public contact
    Noemi Reguart, Noemi Reguart, 34 932275402na, nreguart@clinic.ub.es
    Scientific contact
    Noemi Reguart, Noemi Reguart, 34 932275402na, nreguart@clinic.ub.es
    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
    15 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Co-primary variable 1: Evaluate the baseline results of the tumor to the treatment in terms of blood flow, blood volume, time at peak enhancement and permeability, and correlate it with the objective response (RC+ RP) (according to RECIST 1.1) to day +42. Co-primary variable 2: Evaluate the results of the tumor's early response (day +7) to treatment in terms of blood flow, blood volume, time at peak enhancement and permeability, and correlate it with objective response (RC+ RP) (according to RECIST 1.1) per day + 42.
    Protection of trial subjects
    All subjects received standard supportive care as determined by their treating physician. There is no prohibit supportive treatment. Any treatment for previous or concurrent diagnosed non malignant disease is allowed.
    Background therapy
    All subjects received standard supportive care as determined by their treating physician.
    Evidence for comparator
    NOT APPLICABLE
    Actual start date of recruitment
    11 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 17
    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
    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)
    7
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    STUDY PERIOD: From: 24 July 2013 To: 13 September 2016 CENTERS: Hospital Clínic Barcelona. PHASE OF DEVELOPMENT: Phase IV

    Pre-assignment
    Screening details
    locally advanced or metastatic (IIIB/IV) non-squamous non-small-cell lung cancer (NSCLC). Patients with asymptomatic treated brain metastases are eligible for trial participation. Patient with evidence of tumor compressing or invading a main blood vessel on imaging studies cannot be included.

    Pre-assignment period milestones
    Number of subjects started
    17
    Number of subjects completed
    16

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    progression of disease: 1
    Period 1
    Period 1 title
    Valid patients for assesment. (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    No RECIST responders at day +42
    Arm description
    Patients with PD or ST at day +42
    Arm type
    NON RESPONDERS

    Investigational medicinal product name
    gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1250 mg/m2 days 1 and 8/3 weeks during 6 weeks

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    bevacizumab 7.5 mg/Kg/3 weeks until progression or toxicity.

    Investigational medicinal product name
    CDDP
    Investigational medicinal product code
    Other name
    Cisplatinum
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion, Concentrate for solution for injection, Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatino 80 mg/ m2 IV el day 1/3 weeks during 6 weeks

    Arm title
    RECIST responders at day +42
    Arm description
    Patients with RECIST response at day +42
    Arm type
    RECIST responders

    Investigational medicinal product name
    CDDP
    Investigational medicinal product code
    Other name
    Cisplatinum
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion, Concentrate for solution for injection, Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatino 80 mg/ m2 IV el day 1/3 weeks during 6 weeks

    Investigational medicinal product name
    gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1250 mg/m2 days 1 and 8/3 weeks during 6 weeks

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    bevacizumab 7.5 mg/Kg/3 weeks until progression or toxicity.

    Number of subjects in period 1 [1]
    No RECIST responders at day +42 RECIST responders at day +42
    Started
    12
    4
    Completed
    12
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 17 patients began a conventional treatment designed to analyze a possible relation between Ct Scan characteristics and RECIST responses at day +42. A patient did not a radiologic evaluation at day +42, and he is invalid for the analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Valid patients for assesment.
    Reporting group description
    -

    Reporting group values
    Valid patients for assesment. Total
    Number of subjects
    16 16
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    7 7
        From 65-84 years
    9 9
        85 years and over
    0 0
    Age continuous
    Units: years
        median (standard deviation)
    66.0 ± 10.804 -
    Gender categorical
    Units: Subjects
        Female
    2 2
        Male
    14 14
        Not recorded
    0 0

    End points

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    End points reporting groups
    Reporting group title
    No RECIST responders at day +42
    Reporting group description
    Patients with PD or ST at day +42

    Reporting group title
    RECIST responders at day +42
    Reporting group description
    Patients with RECIST response at day +42

    Primary: Evaluate the difference between day +7 and baseline blood flow, blood volume, permeability, and correlate it with the objective response at day +42.

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    End point title
    Evaluate the difference between day +7 and baseline blood flow, blood volume, permeability, and correlate it with the objective response at day +42.
    End point description
    Evaluate the results of the tumor's early response (day +7) to treatment in terms of blood flow, blood volume, time at peak enhancement and permeability, and correlate it with objective response (RC+ RP) (according to RECIST 1.1) at day + 42.
    End point type
    Primary
    End point timeframe
    base line, day +7 and day +42
    End point values
    No RECIST responders at day +42 RECIST responders at day +42
    Number of subjects analysed
    12
    4
    Units: Ml/min
    number (not applicable)
        Base line blood flow
    12
    4
        Base line blood volume
    12
    4
        baseline blood enhacement and permeability
    12
    4
        Blood flow at day +7
    12
    4
        blood volume alt day +7
    12
    4
        blood enhacement and permeability at day +7
    12
    4
    Statistical analysis title
    Blood flow change between baseline and day +7
    Comparison groups
    No RECIST responders at day +42 v RECIST responders at day +42
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Blood volume change between baseline and day +7
    Comparison groups
    No RECIST responders at day +42 v RECIST responders at day +42
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Permeability change between baseline and day +7
    Comparison groups
    No RECIST responders at day +42 v RECIST responders at day +42
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    11-04-2012 to 13-09-2016
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    -

    Serious adverse events
    Arm 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 17 (47.06%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    1
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dysarthria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    esophagitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    21
    Phlebitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Surgical and medical procedures
    Abscess drainage
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    16 / 17 (94.12%)
         occurrences all number
    64
    Chest pain
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    7
    Pyrexia
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    7
    general deteroriation of physical condition
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    facial edema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infusion site phlebitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Adverse reactions to drugs
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Abstinence syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Lesion
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    7
    Weight decreased
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Increased blood alkaline phosphatase
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Cranial malformation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    peripheral edema
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Neutropenia
         subjects affected / exposed
    12 / 17 (70.59%)
         occurrences all number
    45
    Anemia
         subjects affected / exposed
    10 / 17 (58.82%)
         occurrences all number
    17
    Thrombocytopenia
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    34
    Leukopenia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Thrombocytosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Thoracic pain
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    6
    Dysphonia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Hiccups
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    5
    Cough
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    4
    Hemoptysis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    12
    Headache
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Neurotoxicity
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Decreased visual acuity
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Hypoacusis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hearing disability
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    10 / 17 (58.82%)
         occurrences all number
    21
    Constipation
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    10
    Diarrhoea
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    8
    Abdominal pain upper
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    5
    Gastritis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Rectal haemorrhage
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dysphagia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    dental pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    esophagitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hemorrhoidal bleeding
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    mouth aphtha
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Mucosal inflammation
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    8
    Gingivitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    5
    Dysuria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Acute kidney injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    8
    Dermatitis acneiform
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Erythema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Madarosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Petechiae
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    5
    Pain in extremity
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Neck pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Clubbed fingers
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypertrophyc osteoarthropathy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tendinitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 17 (52.94%)
         occurrences all number
    16
    Hypocalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    4
    Hypomagnesaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cell death
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    1
    Balanitis candida
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Furuncle
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dental infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tinea infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2013
    Non relevant amendment.
    31 Jul 2013
    Non relevant amendment.
    24 Nov 2014
    The reason for this relevant amendment is to modify the exclusion criteria to allow the inclusion of patients according to more realistic criteria consistent with clinical practice. In addition, another minor change is made, consisting of modifying Appendix 6, which replaces the Du Bois normogram with the Mosteller formula for body surface determination (SC), and thus adapting it to the usual clinical practice of the center.
    10 Nov 2015
    The reason for this relevant amendment is to shorten the follow-up period of patients and extend the study recruitment period in order to complete the inclusion of patients (n.20), and thus achieve the primary objective of the study. In this way, the follow-up period will be reduced for the last patients included in the study, however, a high average follow-up would be maintained taking into account the entire study population included since the start of recruitment (first patient included on July 26, 2013).

    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.
    Although the percentage change in blood volume has reached statistical significance, the number of patients is very small and should therefore be confirmed in a larger study.
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