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    Clinical Trial Results:
    A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

    Summary
    EudraCT number
    2014-004837-13
    Trial protocol
    IE   SE   GB   DK   IT   NL   DE   ES  
    Global end of trial date
    20 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Aug 2017
    First version publication date
    25 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VX14-661-106
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02347657
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States, 022101862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001640-PIP01-14
    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
    21 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 24 in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Jan 2015
    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
    Spain: 58
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    Switzerland: 26
    Country: Number of subjects enrolled
    United Kingdom: 48
    Country: Number of subjects enrolled
    United States: 102
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Ireland: 19
    Country: Number of subjects enrolled
    Italy: 45
    Country: Number of subjects enrolled
    Netherlands: 50
    Worldwide total number of subjects
    510
    EEA total number of subjects
    357
    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)
    118
    Adults (18-64 years)
    392
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted across 91 sites in 12 countries.

    Pre-assignment
    Screening details
    A total of 510 subjects were randomized and 509 subjects were treated in the study.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo matched to VX-661 plus IVA in the morning and placebo matched to IVA in the evening up to Week 24.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (matched to VX-661 plus IVA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to VX-661 plus IVA fixed dose combination (FDC) in the morning up to Week 24.

    Investigational medicinal product name
    Placebo (matched to IVA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to IVA in the evening up to Week 24.

    Arm title
    VX-661/IVA
    Arm description
    VX-661 plus IVA in the morning and IVA in the evening up to Week 24.
    Arm type
    Experimental

    Investigational medicinal product name
    VX-661 Plus IVA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    VX-661 plus IVA FDC in the morning up to Week 24.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    VX-770
    Other name
    Kalydeco
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IVA in the evening up to Week 24.

    Number of subjects in period 1
    Placebo VX-661/IVA
    Started
    259
    251
    Treated
    258
    251
    Completed
    241
    236
    Not completed
    18
    15
         Physician decision
    -
    1
         Adverse event
    8
    4
         Unspecified
    3
    3
         Consent withdrawn by subject
    6
    7
         Randomised but not treated
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to VX-661 plus IVA in the morning and placebo matched to IVA in the evening up to Week 24.

    Reporting group title
    VX-661/IVA
    Reporting group description
    VX-661 plus IVA in the morning and IVA in the evening up to Week 24.

    Reporting group values
    Placebo VX-661/IVA Total
    Number of subjects
    259 251 510
    Age categorical
    Units: Subjects
        <18 Years
    60 58 118
        >=18 Years
    199 193 392
    Gender categorical
    Units: Subjects
        Female
    126 121 247
        Male
    133 130 263

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to VX-661 plus IVA in the morning and placebo matched to IVA in the evening up to Week 24.

    Reporting group title
    VX-661/IVA
    Reporting group description
    VX-661 plus IVA in the morning and IVA in the evening up to Week 24.

    Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24

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    End point title
    Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 12 to 17 years and for female subjects aged 12 to 15 years. Full Analysis Set (FAS) included all randomized subjects who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of subjects analysed' signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Through Week 24
    End point values
    Placebo VX-661/IVA
    Number of subjects analysed
    256
    245
    Units: percent predicted of FEV1
        least squares mean (standard error)
    -0.6 ± 0.3
    3.4 ± 0.3
    Statistical analysis title
    Change in percent predicted FEV1 Through Week 24
    Comparison groups
    Placebo v VX-661/IVA
    Number of subjects included in analysis
    501
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed model for repeated measures (MMRM)
    Parameter type
    Least Squares (LS) Mean Difference
    Point estimate
    4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.1
         upper limit
    4.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Week 28
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to VX-661 plus IVA in the morning and placebo matched to IVA in the evening up to Week 24.

    Reporting group title
    VX-661/IVA
    Reporting group description
    VX-661 plus IVA in the morning and IVA in the evening up to Week 24.

    Serious adverse events
    Placebo VX-661/IVA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 258 (18.22%)
    31 / 251 (12.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    3 / 258 (1.16%)
    3 / 251 (1.20%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Benign intracranial hypertension
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    32 / 258 (12.40%)
    23 / 251 (9.16%)
         occurrences causally related to treatment / all
    0 / 38
    1 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 251 (0.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo VX-661/IVA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    243 / 258 (94.19%)
    227 / 251 (90.44%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    13 / 258 (5.04%)
    8 / 251 (3.19%)
         occurrences all number
    13
    8
    Bacterial test positive
         subjects affected / exposed
    16 / 258 (6.20%)
    8 / 251 (3.19%)
         occurrences all number
    19
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    83 / 258 (32.17%)
    66 / 251 (26.29%)
         occurrences all number
    114
    84
    Sputum increased
         subjects affected / exposed
    42 / 258 (16.28%)
    36 / 251 (14.34%)
         occurrences all number
    48
    41
    Haemoptysis
         subjects affected / exposed
    33 / 258 (12.79%)
    24 / 251 (9.56%)
         occurrences all number
    43
    30
    Oropharyngeal pain
         subjects affected / exposed
    29 / 258 (11.24%)
    22 / 251 (8.76%)
         occurrences all number
    36
    23
    Dyspnoea
         subjects affected / exposed
    18 / 258 (6.98%)
    16 / 251 (6.37%)
         occurrences all number
    24
    18
    Rhinorrhoea
         subjects affected / exposed
    16 / 258 (6.20%)
    8 / 251 (3.19%)
         occurrences all number
    17
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    36 / 258 (13.95%)
    44 / 251 (17.53%)
         occurrences all number
    59
    57
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    32 / 258 (12.40%)
    28 / 251 (11.16%)
         occurrences all number
    38
    39
    Fatigue
         subjects affected / exposed
    30 / 258 (11.63%)
    16 / 251 (6.37%)
         occurrences all number
    33
    19
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    22 / 258 (8.53%)
    23 / 251 (9.16%)
         occurrences all number
    29
    28
    Nausea
         subjects affected / exposed
    18 / 258 (6.98%)
    23 / 251 (9.16%)
         occurrences all number
    21
    26
    Diarrhoea
         subjects affected / exposed
    23 / 258 (8.91%)
    17 / 251 (6.77%)
         occurrences all number
    32
    21
    Vomiting
         subjects affected / exposed
    15 / 258 (5.81%)
    13 / 251 (5.18%)
         occurrences all number
    17
    13
    Abdominal pain upper
         subjects affected / exposed
    17 / 258 (6.59%)
    10 / 251 (3.98%)
         occurrences all number
    21
    12
    Constipation
         subjects affected / exposed
    14 / 258 (5.43%)
    7 / 251 (2.79%)
         occurrences all number
    14
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    13 / 258 (5.04%)
    4 / 251 (1.59%)
         occurrences all number
    16
    4
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    75 / 258 (29.07%)
    57 / 251 (22.71%)
         occurrences all number
    105
    73
    Nasopharyngitis
         subjects affected / exposed
    39 / 258 (15.12%)
    42 / 251 (16.73%)
         occurrences all number
    55
    54
    Rhinitis
         subjects affected / exposed
    14 / 258 (5.43%)
    10 / 251 (3.98%)
         occurrences all number
    15
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Mar 2015
    - Addition of Cystic Fibrosis Questionnaire-Revised (CFQ-R) assessment at selected Visits.
    08 Jun 2015
    - Addition of post-dose spirometry and ophthalmologic examinations.
    06 May 2016
    - Revised exclusion criterion to exclude subjects who received lumacaftor/ivacaftor commercially.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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