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    Clinical Trial Results:
    A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® in combination with Vitamin D on the progression to type 1 diabetes in children with multiple islet cell autoantibodies

    Summary
    EudraCT number
    		 2014-003755-64
    Trial protocol
    		 SE  
    Global end of trial date
    07 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Sep 2020
    First version publication date
    26 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DiAPREV/2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02387164
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Skåne University Hospital
    Sponsor organisation address
    Jan Waldenströms gata 35, Malmö, Sweden, 20502
    Public contact
    Helena Elding Larsson, Skåne University Hospital, 46 040337676, helena.larsson@med.lu.se
    Scientific contact
    Helena Elding Larsson, Skåne University Hospital, 46 040337676, helena.larsson@med.lu.se
    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
    05 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate if Diamyd®, in children treated with relatively high dose vitamin D, may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta cell autoimmunity as indicated by multiple positive islet cell autoantibodies.
    Protection of trial subjects
    After the injection of Diamyd/placebo at visits 1 and 2, each trial participant was to remain at the study clinic for at least 1 h and monitored by the study personnel. Additionally, the participants were offered to stay at the clinic for an additional 2h or contact the investigator by phone.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Mar 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    24
    Adolescents (12-17 years)
    5
    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
    		 The study was stopped prematurely after only 29 patients recruited and maximum 2 years follow up.

    Pre-assignment
    Screening details
    		 29 patients were screened and 26 entered the study

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ALUM-rhGAD65 + Vitamin D
    Arm description
    		 Diamyd with Vitamin D supplementation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    ALUM-rhGAD65
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One injection of 20 microgram Diamyd 2 times with 1 month apart

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2000 IE daily

    Arm title
    		 Placebo + Vitamin D
    Arm description
    		 Placebo with vitamin D supplementation
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One injection 2 times with one month apart

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2000 IU daily

    Number of subjects in period 1 [1]
    		ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Started
    13
    13
    Completed
    13
    13
    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: 3 subjects dropped out after the screening visit before the randomization.
    Period 2
    Period 2 title
    Treatment follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ALUM-rhGAD65 + Vitamin D
    Arm description
    		 Diamyd with Vitamin D supplementation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    ALUM-rhGAD65
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One injection of 20 microgram Diamyd 2 times with 1 month apart

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2000 IU daily

    Arm title
    		 Placebo + Vitamin D
    Arm description
    		 Placebo plus Vitamin D supplementation
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One injection 2 times with 1 month apart

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2000 IU daily

    Number of subjects in period 2
    		ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Started
    13
    13
    Completed
    10
    11
    Not completed
    3
    2
         Lost to follow-up
    2
    -
         Diagnosed
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ALUM-rhGAD65 + Vitamin D
    Reporting group description
    		 Diamyd with Vitamin D supplementation

    Reporting group title
    Placebo + Vitamin D
    Reporting group description
    		 Placebo with vitamin D supplementation

    Reporting group values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D Total
    Number of subjects
    		 13 13 26
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 10 11 21
        Adolescents (12-17 years)
    		 3 2 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9 ( 2.89 ) 9.4 ( 2.73 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 4 11
        Male
    		 6 9 15
    Celiac disease
    Units: Subjects
        No
    		 11 13 24
        Yes
    		 2 0 2
    Thyroid disease
    Units: Subjects
        No
    		 13 13 26
        Yes
    		 0 0 0
    Relatedness
    Units: Subjects
        First degree relative
    		 4 2 6
        General population
    		 9 11 20
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 33.7 ( 14.51 ) 36.6 ( 14.99 ) -

    End points

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    End points reporting groups
    Reporting group title
    ALUM-rhGAD65 + Vitamin D
    Reporting group description
    		 Diamyd with Vitamin D supplementation

    Reporting group title
    Placebo + Vitamin D
    Reporting group description
    		 Placebo with vitamin D supplementation
    Reporting group title
    ALUM-rhGAD65 + Vitamin D
    Reporting group description
    		 Diamyd with Vitamin D supplementation

    Reporting group title
    Placebo + Vitamin D
    Reporting group description
    		 Placebo plus Vitamin D supplementation

    Primary: Type 1 diabetes status month 24

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    End point title
    		 Type 1 diabetes status month 24 [1]
    End point description
    Number of subjects diagnosed with Type 1 diabetes at month 24
    End point type
    Primary
    End point timeframe
    Month 24
    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: The study was interrupted prematurely when only 13 subjects were randomized to each treatment group. Only descriptive statistics were planned according to the SAP.
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    13
    13
    Units: Number of subjects
        Yes
    1
    2
        No
    12
    11
    No statistical analyses for this end point

    Primary: Type 1 diabetes status overall

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    End point title
    		 Type 1 diabetes status overall [2]
    End point description
    Number of subjects diagnosed with Type 1 diabetes overall in the study
    End point type
    Primary
    End point timeframe
    Over the entire study period including after month 24
    Notes
    [2] - 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: The study was interrupted prematurely when only 13 subjects were randomized to each treatment group. Only descriptive statistics were planned according to the SAP.
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    13
    13
    Units: Number of subjects
        Yes
    2
    2
        No
    11
    11
    No statistical analyses for this end point

    Secondary: Develompent of impaired glucose metabolism

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    End point title
    		 Develompent of impaired glucose metabolism
    End point description
    Number of subjects developing impaired glucose metabolism by month 18
    End point type
    Secondary
    End point timeframe
    Month 18
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    8
    6
    Units: Number of subjects
        Yes
    3
    1
        No
    5
    5
    No statistical analyses for this end point

    Secondary: Progressive impaired glucose metabolism

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    End point title
    		 Progressive impaired glucose metabolism
    End point description
    Number of subjects with progressive impaired glucose metabolism at month 18
    End point type
    Secondary
    End point timeframe
    Month 18
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    2
    4
    Units: Number of subjects
        Yes
    1
    0
        No
    1
    4
    No statistical analyses for this end point

    Secondary: Injection site reactions day 1

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    End point title
    		 Injection site reactions day 1
    End point description
    Number of subjects experiencing injection site reactions at Day 1
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    13
    13
    Units: Number of subjects
        Erythema
    0
    0
        Haematoma
    0
    0
        Itching
    0
    0
        Oedema
    0
    0
        Pain
    0
    0
        Tenderness
    0
    0
    No statistical analyses for this end point

    Secondary: Injection site reactions month 1

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    End point title
    		 Injection site reactions month 1
    End point description
    Number of subjects experiencing injection site reacations
    End point type
    Secondary
    End point timeframe
    Month 1
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    13
    13
    Units: Number of subjects
        Erythema
    1
    0
        Haematoma
    1
    0
        Itching
    0
    0
        Oedema
    2
    0
        Pain
    0
    0
        Tenderness
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in GADA month 1

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    End point title
    		 Change from baseline in GADA month 1
    End point description
    Change from baseline to month 1 in GADA titers
    End point type
    Secondary
    End point timeframe
    Change from baseline to month 1
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    13
    12
    Units: U/mL
        arithmetic mean (standard deviation)
    1619.1 ( 2608.9 )
    -51.9 ( 197.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline in GADA month 12

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    End point title
    		 Change from baseline in GADA month 12
    End point description
    Change from baseline to month 12 in GADA titers
    End point type
    Secondary
    End point timeframe
    Change from baseline to month 12
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    10
    10
    Units: U/mL
        arithmetic mean (standard deviation)
    7916.9 ( 10694.55 )
    -120.9 ( 592.09 )
    No statistical analyses for this end point

    Secondary: Change from baseline in GADA month 24

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    End point title
    		 Change from baseline in GADA month 24
    End point description
    Change from baseline to month 24 in GADA titers
    End point type
    Secondary
    End point timeframe
    Change from baseline to month 24
    End point values
    		 ALUM-rhGAD65 + Vitamin D Placebo + Vitamin D
    Number of subjects analysed
    9
    11
    Units: U/mL
        arithmetic mean (standard deviation)
    3216.6 ( 4628.53 )
    1062.7 ( 3380.26 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization up to 2 year follow-up or diagnosis of type 1 diabetes.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    ALUM-rhGAD65 + Vitamin D
    Reporting group description
    		 Diamyd with Vitamin D supplementation

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 ALUM-rhGAD65 + Vitamin D Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Post streptococcal glomerulonephritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (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
    		 ALUM-rhGAD65 + Vitamin D Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 13 (92.31%)
    12 / 13 (92.31%)
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Upper limb fracture
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Injury
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 13 (38.46%)
    3 / 13 (23.08%)
         occurrences all number
    13
    9
    Migraine
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 13 (30.77%)
    5 / 13 (38.46%)
         occurrences all number
    6
    11
    Pain
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injection site rash
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Vertigo
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 13 (15.38%)
         occurrences all number
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Food poisoning
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 13 (7.69%)
         occurrences all number
    3
    2
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Depression
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Growing pains
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 13 (76.92%)
    9 / 13 (69.23%)
         occurrences all number
    49
    20
    Ear infection
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 13 (7.69%)
         occurrences all number
    3
    3
    Influenza
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    Pharyngitis
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Otitis media
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Tooth infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Enterobiasis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    Febrile infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    This study was stopped prematurely when only 26 out of 80 patients were recruited and followed for maximum 2 years rather than planned 5 years.
    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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