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    Clinical Trial Results:
    Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients

    Summary
    EudraCT number
    2011-000801-39
    Trial protocol
    DE   SE   BE   IT   IE   HU   AT   ES  
    Global end of trial date
    27 Jun 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Apr 2019
    First version publication date
    12 Apr 2019
    Other versions
    Summary report(s)
    2018_12_14_IMPACTT_PsAer-IgY_FinalReportSynopsis_V01-F

    Trial information

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    Trial identification
    Sponsor protocol code
    PsAer-IgY
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01455675
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    clinicaltrials.gov: NCT01455675
    Sponsors
    Sponsor organisation name
    Mukoviszidose Institute gGmbH
    Sponsor organisation address
    In den Dauen 6, Bonn, Germany, 53117
    Public contact
    Sponsor´s Project Manager , Mukoviszidose Institute gGmbH , +49 228987800, impactt@muko.info
    Scientific contact
    Sponsor´s Project Manager , Mukoviszidose Institute gGmbH , +49 228987800, impactt@muko.info
    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
    14 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to find out, if continuous long-term local application of specific egg yolk antibodies (IgY) directed against PA - initiated after successfully treated acute PA infection - can prolong the time to recurrence of a sputum culture positive for PA. The objective to prevent infections with PA is also to diminish the need of antibiotics and minimize the problem of bacterial resistance against antibiotics.
    Protection of trial subjects
    Since eggs represent normal dietary components there is practically no risk of toxic side effects of IgY. Accordingly, adverse reactions have never been detected so far. Regarding the assessment of the immunogenic potential of IgY which - under theoretical considerations - might reduce treatment efficacy by the induction of human anti IgY antibodies, it is important to stress that IgY is not immunogenic in humans, when it is given orally (Larsson et al 1991). Patients with history of allergy/hypersensitivity to hens' egg proteins (including medication allergy) that is deemed relevant to the trial by the investigator are excluded from the trial. “Relevance” in this context refers to any increased risk of hypersensitivity reaction to trial medication. Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data are an exclusion criteria as well. This includes, but is not limited to, significant hematological, hepatic, renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior to inclusion). Patients who are pregnant cannot be included into the study. This will be tested at inclusion visit with a urine pregnancy test (in female patients older than 10 years with secondary sexual characteristics) Insurance coverage is provided by Atrialis GmbH and Elscher Consulting respectively as stipulated by law, for all patients enrolled in the study from the time of patients„ inclusion into the study. This insurance covers any damage to health arising from participation in the study up to maximum sum required by law.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2011
    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
    Poland: 19
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Germany: 70
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Ireland: 9
    Country: Number of subjects enrolled
    Italy: 13
    Worldwide total number of subjects
    164
    EEA total number of subjects
    164
    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)
    100
    Adolescents (12-17 years)
    39
    Adults (18-64 years)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 47 sites in Germany, Belgium, Ireland, Sweden, Hungary, Poland, Austria, Italy and Spain. Patient recruitment took place from November 2011 to June 2015. first patient screened: 14NOV2011 first patient included: 29NOV2011 last patient included:

    Pre-assignment
    Screening details
    Patients from 5 years of age were included if they had a proven diagnosis of cystic fibrosis and had had a prior bronchopulmonary infection with Pseudomonas aeruginosa in the past 3 years that had been eradicated at the time of inclusion into 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, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    IgY gargling solution Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily.
    Arm type
    Experimental

    Investigational medicinal product name
    avian polyclonal IgY antibody against Pseudomonas aeruginosa
    Investigational medicinal product code
    Anti-Pseudomonas IgY
    Other name
    Pharmaceutical forms
    Gargle
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Gargling of 50 ml solution per day at night after teeth brushing before bed, containing 50 mg of Anti-Pseudomonas IgY with an activity of > or = 5 FKU (Fresenius Calvi units) / ml ELISA unit / ml enzyme-linked immunosorbent assay unit / millitre

    Arm title
    Placebo
    Arm description
    Avian gargling solution containing unspecific IgY antibody as Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo with unspecific anvian polyclonal IgY antibodies
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gargle
    Routes of administration
    Oromucosal use
    Dosage and administration details
    gargling of 50 ml placebo solution per day at night after teeth brushing before bed.

    Number of subjects in period 1
    Verum Placebo
    Started
    83
    81
    Completed
    83
    81

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    REMARK: A total of 171 patients were randomized to placebo (n=86) or to treatment (n=85). From the 86 patients allocated to placebo, only 81 received intervention, 5 patients declined to participate before receiving the intervention. From the 85 patients allocated to treatment, only 83 received intervention, 1 patient declined to participate before receiving the intervention and 1 patient had a PA infection before receiving the intervention. These 7 patients who dropped out before receiving intervention were not included in the database of the study and therefore were not considered in this report. In conclusion the overall trial reporting group of 164 subjects consists of 81 patients of the placebo group and 83 patients of the treatment group.

    Reporting group values
    overall trial Total
    Number of subjects
    164 164
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    100 100
        Adolescents (12-17 years)
    39 39
        Adults (18-64 years)
    25 25
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    82 82
        Male
    82 82
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all enrolled patients who received at least one dose of assigned treatment. Following the intent-to-treat principle, patients are analyzed according to the treatment assigned by randomisation.

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety population (SAF) consists of all patients who received at least one dose of study treatment Patients are analyzed according to the treatment received.

    Subject analysis sets values
    Full analysis set Safety population
    Number of subjects
    164
    164
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    100
    100
        Adolescents (12-17 years)
    39
    39
        Adults (18-64 years)
    25
    25
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    82
    82
        Male
    82
    82

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    IgY gargling solution Avian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily.

    Reporting group title
    Placebo
    Reporting group description
    Avian gargling solution containing unspecific IgY antibody as Placebo

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all enrolled patients who received at least one dose of assigned treatment. Following the intent-to-treat principle, patients are analyzed according to the treatment assigned by randomisation.

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety population (SAF) consists of all patients who received at least one dose of study treatment Patients are analyzed according to the treatment received.

    Primary: Time_to_Infection

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    End point title
    Time_to_Infection
    End point description
    The confirmatory analysis of the primary endpoint was performed for the FAS. Additional efficacy analyses were conducted for the PP-population. The primary efficacy endpoint was analyzed using a log rank test. Superiority of IgY would be claimed if the p-value from the comparison is <0.0115 at the interim, or <0.0464 at the final analysis. The median time to event for each treatment group was derived from a Kaplan-Meier analysis including a 95 % confidence interval for the medians. Patients without an event were censored at the time of withdrawal, or after 24 months. In Addition to the log rank test, a Cox Regression was performed with the Group Treatment adjusted by history of PA, Gender, Age (children/adults) and FEV (greater/smaller than median).
    End point type
    Primary
    End point timeframe
    Primary study endpoint was defined as the differences between gargling with Anti-pseudomonas IgY & gargling with placebo with respect to time from day 0 to recurrence of PA in sputum within the period of up to 104 weeks.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83 [1]
    81 [2]
    164
    Units: days of gargling
        number (not applicable)
    83
    81
    164
    Notes
    [1] - n=1 declined to participate. n=1 infection before received mediation.
    [2] - (n=5) declined to participate.
    Statistical analysis title
    Statistical analysis of the primary endpoint
    Statistical analysis description
    The primary efficacy endpoint is analysed using a log rank test. The null hypothesis is that there is no difference in time to recurrence of PA in the sputum of active treatment and placebo, respectively. The alternative hypothesis is that the active treatment is superior. Superiority of IgY will be claimed if the p-value from the comparison is < 0.0464 at the final Analysis (an Interim Analysis was planed with a p-value smaller than 0.0115).
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9469
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.002
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.215
         upper limit
    34.55

    Secondary: FEV1

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    End point title
    FEV1
    End point description
    Change of the FEV1 values over time.
    End point type
    Secondary
    End point timeframe
    Period from baseline to end of study, where data have been collected at planned visits every 13 weeks.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83
    81
    164
    Units: Forced Expidatory Volume in 1 sec
        number (not applicable)
    83
    81
    164
    Statistical analysis title
    Statistical analysis for FEV1
    Statistical analysis description
    A preliminary longitudinal analysis was performed with a linear mixed effects model using classical techniques. This analysis shows that the data contains outliers and the assumption of normally distributed residuals was violated. For this reason, we developed a full Bayesian analysis which relaxes those model’s assumptions. In addition, this model is robust against outliers. The conclusions of this statistical analysis are based on the Bayesian analysis.
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Slope
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.002
         upper limit
    0.001

    Secondary: Number of Exacerbations

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    End point title
    Number of Exacerbations
    End point description
    This is a comparison of the number of exacerbations between the treated groups. An exacerbation will be defined as change in at least two of the following signs: 1. Change in sputum volume or colour 2. Increased cough 3. Increased malaise, fatigue or lethargy 4. Anorexia or weight loss 5. Decrease in pulmonary function by 10% or more /Radiologic changes 6. Increased dyspnoea
    End point type
    Secondary
    End point timeframe
    The total number of exacerbations, from screening visit to end of study counted for each patient.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83
    81
    164
    Units: number of exacerbations
    83
    81
    164
    Statistical analysis title
    Analysis of the number of exacerbations
    Statistical analysis description
    A Poisson regression model was planned for analysis but it was not appropriate to explain the data. The Residual Deviance was larger than the number of degrees of freedom. Therefore, we cannot rely on the results of this model. Conclusions are based on the Negative Binomial regression model, which fitted the data better (the residual deviance was smaller than the degrees of freedom).
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    [3]
    P-value
    = 0.36
    Method
    Negative Binomial regression
    Parameter type
    Log odds ratio
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.23
         upper limit
    0.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.421
    Notes
    [3] - A Negative Binomial regression model is applied, where treatment group effect is adjusted by gender and age at baseline (children/adults).

    Secondary: Days of illness in hospital

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    End point title
    Days of illness in hospital
    End point description
    This is a comparison of the number of days in hospitals between the treated groups.
    End point type
    Secondary
    End point timeframe
    The total number of days in hospital, from screening visit to end of study counted for each patient.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83
    81
    164
    Units: days in hospital
    83
    81
    164
    Statistical analysis title
    Statistical analysis of days in hospital
    Statistical analysis description
    A Poisson regression model was planned for analysis but it was not appropriate to explain the data. The Residual Deviance was larger than the number of degrees of freedom. Therefore, we cannot rely on the results of this model. Conclusions are based on the Negative Binomial regression model, which fitted the data better (the residual deviance was smaller than the degrees of freedom).
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.9
    Method
    Negative Binomial regresssion.
    Parameter type
    Log odds ratio
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.57
         upper limit
    1.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6525
    Notes
    [4] - A Negative Binomial regression model is applied, where treatment group effect is adjusted by gender and age at baseline (children/adults).

    Secondary: Days out of school or work (sick leave)

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    End point title
    Days out of school or work (sick leave)
    End point description
    This is a comparison of the number of days out of school or work between the treated groups.
    End point type
    Secondary
    End point timeframe
    The total number of days (sick leave) out of school or work, from screening visit to end of study counted for each patient.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83
    81
    164
    Units: days not in school/work
    83
    81
    164
    Statistical analysis title
    Statistical analysis for days out of school/work
    Statistical analysis description
    A Poisson regression model was planned for analysis but it was not appropriate to explain the data. The Residual Deviance was larger than the number of degrees of freedom. Therefore, we cannot rely on the results of this model. Conclusions are based on the Negative Binomial regression model, which fitted the data better (the residual deviance was smaller than the degrees of freedom).
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    = 0.211
    Method
    Negative binomial regression
    Parameter type
    Log odds ratio
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.87
         upper limit
    0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.265
    Notes
    [5] - A Negative Binomial regression model is applied, where treatment group effect is adjusted by gender and age at baseline (children/adults).

    Secondary: Days of use of antibiotics treatment

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    End point title
    Days of use of antibiotics treatment
    End point description
    This is a comparison of the number of days of use of antibiotics between the treated groups.
    End point type
    Secondary
    End point timeframe
    The total number of days of use of antibiotics, from screening visit to end of study counted for each patient.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    82 [6]
    79 [7]
    161 [8]
    Units: days of antibiotic treatment
    82
    79
    161
    Notes
    [6] - Missing information from one patient.
    [7] - Missing information from two patients.
    [8] - Missing information from three patients.
    Statistical analysis title
    Statistical analysis of use of antibiotics
    Statistical analysis description
    A Poisson regression model was planned for analysis but it was not appropriate to explain the data. The Residual Deviance was larger than the number of degrees of freedom. Therefore, we cannot rely on the results of this model. Conclusions are based on the Negative Binomial regression model, which fitted the data better (the residual deviance was smaller than the degrees of freedom).
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.52
    Method
    Negative Binomial regression.
    Parameter type
    Log odds ratio
    Point estimate
    -0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -57
         upper limit
    0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.217
    Notes
    [9] - A Negative Binomial regression model is applied, where treatment group effect is adjusted by gender and age at baseline (children/adults).

    Secondary: BMI

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    End point title
    BMI
    End point description
    Change of the BMI values over time.
    End point type
    Secondary
    End point timeframe
    Period from baseline to end of study, where data have been collected at planned visits every 13 weeks.
    End point values
    Verum Placebo Full analysis set
    Number of subjects analysed
    83
    81 [10]
    164
    Units: kg/m2
        number (not applicable)
    83
    81
    164
    Notes
    [10] - 81
    Statistical analysis title
    Statistical analysis of BMI
    Statistical analysis description
    A preliminary longitudinal analysis was performed with a linear mixed effects model using classical techniques. This analysis shows that the data contains outliers and the assumption of normally distributed residuals was violated. For this reason, we developed a full Bayesian analysis which relaxes those model’s assumptions. In addition, this model is robust against outliers. The conclusions of this statistical analysis are based on the Bayesian analysis.
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Slope
    Point estimate
    0.003
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.001
         upper limit
    0.007

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From inclsuion visit to End of study visit(Termination), plus a follow-up period for SAEs of 30 days after termination for each patient.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: A total number of 1972 AEs was documented, 987 were in the placebo group and 980 in the treatment group. o deaths occurred. There were only few AEs judged to be related to the study drug: 5 adverse events in the treatment group and 20 in the placebo group. None of the adverse events judged to be related to the study drug was serious. In two cases, AEs led to premature withdrawal of the patients, one in the placebo and one in the treatment group. Generally, the study drug was well tolerated.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2011
    Protocol Version 1.3: Definition of chronic PA-infection concretized Exclusion criteria concerning atypic mycobacteria were defined more precisely change in frequency of sample shipment to central laboratory
    20 Apr 2012
    Protocol version 1.4: deletion of precitpitine value >/= 1 as an inclusion criteria, as this is no concrete hint for an acute PA infection. deletion of inclusion criteria "At inclusion no chronic infection with other gram-negative bacteria such as B. cepacica, S. maltophilia & A. xylosoxidans - or atypical mycobacteria or Aspergillus fumigatus" because it might be misleading in regard to one of the exclusion criteria which includes this aspect already.
    13 Jan 2014
    Amendment Protocol version 1.5; Longer stability data of the IMP from 12 months to 24 could be shown. Protocol, Investigator brochure and patient information was adapted to updated IMPD. Exclusion criteria infection with other gram-negative bacteria was defined more precisely including only those gram-negative infections were medication with PA-effective antibiotics is neccessary.

    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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