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    Clinical Trial Results:
    A Prospective 3-year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study with a TMC435-containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

    Summary
    EudraCT number
    2010-019843-20
    Trial protocol
    DE   PL  
    Global end of trial date
    05 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jan 2017
    First version publication date
    12 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC435HPC3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01349465
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, a division of Janssen Pharmaceutica NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Main objective of the study was to evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a simeprevir (SMV)-containing regimen in a previous Phase 2b or Phase 3 study and maintained undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) until the last post-therapy follow-up visit of the previous study (LPVPS) and to evaluate sequence changes in the HCV NS3/4A region over time in subjects who were treated with a SMV-containing regimen in a previous Phase 2b or Phase 3 study and had confirmed detectable HCV RNA at LPVPS.
    Protection of trial subjects
    The safety assessments included laboratory assessments (hematology, serum chemistry, and Coagulation), and Adverse events were monitored throughout the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jul 2011
    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
    Belgium: 27
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Russian Federation: 45
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    249
    EEA total number of subjects
    129
    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)
    237
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    In total 250 subjects were screened and among those 249 were enrolled into the study (200 subjects with SVR and 49 subjects with no SVR).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SVR at LPVPS
    Arm description
    Subjects with sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).
    Arm type
    Follow up Phase (Simeprevir)

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    TMC 435
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects did not receive any treatment during this study and this is the follow up phase for Simeprevir.

    Arm title
    no SVR at LPVPS
    Arm description
    Subjects with no sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    SVR at LPVPS no SVR at LPVPS
    Started
    200
    49
    Completed
    182
    27
    Not completed
    18
    22
         Adverse event
    1
    -
         Adverse event, serious fatal
    3
    -
         Consent withdrawn by subject
    4
    2
         Subject ineligible to continue the trial
    -
    19
         Lost to follow-up
    10
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects with sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).

    Reporting group title
    no SVR at LPVPS
    Reporting group description
    Subjects with no sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).

    Reporting group values
    SVR at LPVPS no SVR at LPVPS Total
    Number of subjects
    200 49 249
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    193 44 237
        From 65 to 84 years
    7 5 12
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    52 (22 to 70) 56 (28 to 70) -
    Title for Gender
    Units: subjects
        Female
    78 17 95
        Male
    122 32 154

    End points

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    End points reporting groups
    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects with sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).

    Reporting group title
    no SVR at LPVPS
    Reporting group description
    Subjects with no sustained virologic response (SVR) at last posttherapy visit of the previous study (LPVPS).

    Primary: Percentage of Subjects Maintaining SVR at the Last Available Visit

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    End point title
    Percentage of Subjects Maintaining SVR at the Last Available Visit [1] [2]
    End point description
    The SVR rate is the proportion (%) of subjects with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    Last Available Visit (Month 36 for subjects completing the study)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data represented only for with SVR LPVPS.
    End point values
    SVR at LPVPS
    Number of subjects analysed
    200
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (98.2 to 100)
    No statistical analyses for this end point

    Primary: Overall Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study

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    End point title
    Overall Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study [3] [4]
    End point description
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in subjects with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. "N" signifies number of subjects with no SVR at LPVPS and with available sequence data. "n" defines the number of subjects analyzed at specified time point.
    End point type
    Primary
    End point timeframe
    Baseline and Month 36
    Notes
    [3] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    no SVR at LPVPS
    Number of subjects analysed
    48
    Units: Percentage of subjects
    number (not applicable)
        NEM Return to Baseline at EOS (n=5)
    0
        NEM Change to New Profile at EOS (n=5)
    0
        AEM Return to Baseline at EOS (n=43)
    86
        AEM Change to New Profile at EOS (n=43)
    7
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA (With Q80K at baseline) at the Last Visit of the Previous Study

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    End point title
    Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA (With Q80K at baseline) at the Last Visit of the Previous Study [5] [6]
    End point description
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in subjects with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. Subjects with no SVR at LPVPS were included in the population analysis set. "N" signifies the number of available subjects with sequence data and "n" defines the number of subjects analyzed at specified time point.
    End point type
    Primary
    End point timeframe
    Baseline and Month 36
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data represented only for with noSVR LPVPS.
    End point values
    no SVR at LPVPS
    Number of subjects analysed
    10
    Units: Percentage of subjects
    number (not applicable)
        NEM Return to Baseline at EOS (n=1)
    0
        NEM Change to New Profile at EOS (n=1)
    0
        AEM Return to Baseline at EOS (n=9)
    88.9
        AEM Change to New Profile at EOS (n=9)
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA (Without Q80K at baseline) at the Last Visit of the Previous Study

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    End point title
    Percentage of Subjects With Change in Sequence of HCV NS3/4A Region Over Time in Subjects With Confirmed Detectable HCV RNA (Without Q80K at baseline) at the Last Visit of the Previous Study [7] [8]
    End point description
    Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in subjects with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study. Subjects with no SVR at LPVPS were included in the population analysis set. "N" signifies the number of available subjects with sequence data and "n" defines the number of subjects analyzed at specified time point.
    End point type
    Primary
    End point timeframe
    Baseline and Month 36
    Notes
    [7] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    no SVR at LPVPS
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (not applicable)
        NEM Return to Baseline at EOS (n=4)
    0
        NEM Change to New Profile at EOS (n=4)
    0
        AEM Return to Baseline at EOS (n=34)
    85.3
        AEM Change to New Profile at EOS (n=34)
    8.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Late Viral Relapse

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    End point title
    Percentage of Subjects With Late Viral Relapse [9]
    End point description
    Relapse at any time after the LPVPS until the last individual visit of this study. All subjects maintained SVR until the last available visit. No late viral relapse was therefore observed. Late viral relapse was evaluated in all enrolled subjects with SVR at LPVPS.
    End point type
    Secondary
    End point timeframe
    End of study (at month 36)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data represented only for with SVR LPVPS.
    End point values
    SVR at LPVPS
    Number of subjects analysed
    200
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability

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    End point title
    Number of Subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability
    End point description
    End point type
    Secondary
    End point timeframe
    End of study (at month 36)
    End point values
    SVR at LPVPS no SVR at LPVPS
    Number of subjects analysed
    200
    49
    Units: subjects
        Adverse Events (AE)
    4
    1
        Serious Adverse Events (SAE)
    10
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study (36 Months)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects with SVR at LPVPS

    Reporting group title
    no SVR at LPVPS
    Reporting group description
    Subjects with No SVR at LPVPS

    Reporting group title
    Total
    Reporting group description
    All enrolled subjects in the study.

    Serious adverse events
    SVR at LPVPS no SVR at LPVPS Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 200 (5.00%)
    0 / 49 (0.00%)
    10 / 249 (4.02%)
         number of deaths (all causes)
    3
    0
    3
         number of deaths resulting from adverse events
    Cardiac disorders
    Myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic neoplasm malignant
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 200 (1.50%)
    0 / 49 (0.00%)
    3 / 249 (1.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Colon cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hydrocholecystis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    SVR at LPVPS no SVR at LPVPS Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 200 (2.00%)
    1 / 49 (2.04%)
    5 / 249 (2.01%)
    Investigations
    Alpha 1 foetoprotein increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 49 (2.04%)
    1 / 249 (0.40%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences all number
    1
    0
    1
    Nervous system disorders
    Dysarthria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences all number
    1
    0
    1
    Hemiparesis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences all number
    1
    0
    1
    Hepatobiliary disorders
    Bile duct stone
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences all number
    1
    0
    1
    Cholecystitis chronic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 49 (0.00%)
    1 / 249 (0.40%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jan 2011
    The main purpose of this amendment was to extended the follow-up period from 1 to 3 years, also added clinical endpoints (eg, liver disease progression).

    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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