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    Clinical Trial Results:
    CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease

    Summary
    EudraCT number
    		 2016-003876-29
    Trial protocol
    		 DK   DE   GB   AT   IT   BE  
    Global end of trial date
    18 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2023
    First version publication date
    09 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GMPO-131-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03539952
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EudraCT Number: 2016-003876-29
    Sponsors
    Sponsor organisation name
    Orphalan SA
    Sponsor organisation address
    226 Boulevard Voltaire, Paris, France, 75011
    Public contact
    Clinical Trials Information, Orphalan SA, 33 1 42 49 82 64, naseem.s.amin@orphalan.com
    Scientific contact
    Clinical Trials Information, Orphalan SA, 33 1 42 49 82 64, naseem.s.amin@orphalan.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
    04 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of trientine tetrahydrochloride compared with penicillamine in stable adult Wilson disease patients tolerant to penicillamine. In this non-inferiority randomised trial, the primary endpoint to determine efficacy is the mean difference of non-ceruloplasmin copper (NCC) in serum between the two treatment groups.
    Protection of trial subjects
    Home visits were implemented to reduce the intensity of the 4-weekly post-randomization period (week 12-36) compared to 1 to 2 times a year for standard of care visits
    Background therapy
    		 Eligible patients were adults aged between 18 and 75 years receiving penicillamine for at least one year for the treatment of Wilson's disease and on a stable dose for at least 4 months prior to enrolment.
    Evidence for comparator
    		 Comparator: The other approved chelator, penicillamine, is effective but known to be associated with a high frequency of adverse reactions. It is reported that approximately 30% of Wilson’s disease patients prescribed penicillamine will experience adverse reactions; in the first 1–3 weeks of the treatment, this includes hyper-sensitivity reactions with fever, rash, lymphadenopathy, neutropenia, thrombocytopenia or total aplasia and proteinuria (Sternlieb and Schienberg, 1968), with long-term use associated with side effects including bone marrow toxicity, nephrotoxicity and lupus-like syndrome and dermopathies (Gibbs and Walshe, 1966; Walshe, 1973; Walshe, 1989; Kumagi et al, 2004; Medici et al, 2007; Weiss et al, 2011).
    Actual start date of recruitment
    09 Feb 2017
    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
    Poland: 12
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Brazil: 17
    Worldwide total number of subjects
    77
    EEA total number of subjects
    54
    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)
    73
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited by selected WD centers. The randomization target was set at 55. Recruitment took place over a period of almost 2 years and ended December 2019

    Pre-assignment
    Screening details
    		 WD patients who are considered to be stable by the site investigator, on their standard-of-care penicillamine chelation therapy for at least 1 year, are eligible and once eligible for the study, will enter a 12-week Penicillamine Baseline Period comprising of 1 month (4 weeks) run-in period followed by a 2 month (8 weeks) evaluation period.

    Pre-assignment period milestones
    Number of subjects started
    		 77
    Number of subjects completed
    		 77

    Period 1
    Period 1 title
    Screen and baseline run-in period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Adjudication to confirm baseline egilibility before randomization were blinded to subject nummer and site number

    Arms
    Arm title
    		 Screen and run-in failures
    Arm description
    		 All subject that were screened, and failed to meet the enrolment criteria between screening and randomization
    Arm type
    		 Baseline run-in

    Investigational medicinal product name
    Penicillamine
    Investigational medicinal product code
    Other name
    D-penicillamine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The total daily dose in milligrams of penicillamine to be administered from Day 1 onwards is the same total daily dose in milligrams as the patient’s maintenance dose of penicillamine prior to enrolment in the study. From Day 1 onwards, the total daily dose is to be administered as two divided doses (BID). If the dose does not divide equally then the higher number of capsules should be taken at the first administration of the day.

    Number of subjects in period 1
    		Screen and run-in failures
    Started
    77
    Completed
    53
    Not completed
    24
         Eligibility criteria not met
    17
         Consent withdrawn by subject
    4
         Physician decision
    1
         Lost to follow-up
    2
    Period 2
    Period 2 title
    Post randomization phase W12-W36
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Penicillamine arm
    Arm description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Penicillamine
    Investigational medicinal product code
    Other name
    D-penicillamine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient will receive its individual daily dose , given as twice daily

    Arm title
    		 Trientine tetrahydrochloride arm
    Arm description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl
    Arm type
    		 Experimental

    Investigational medicinal product name
    TETA 4HCl
    Investigational medicinal product code
    Other name
    trientien tetrahydrochloride, Cuprior
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The total daily dose in milligrams of trientine base has been the same total daily dose in milligrams of penicillamine administered at the end of the Penicillamine Baseline Period at Week 12, rounded to the nearest 150 mg of trientine base. Each patient will receive its individual daily dose, given as twice daily

    Number of subjects in period 2
    		Penicillamine arm Trientine tetrahydrochloride arm
    Started
    27
    26
    Completed
    26
    26
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Period 3
    Period 3 title
    1st Extension phase W36-60
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Penicillamine arm
    Arm description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Penicillamine
    Investigational medicinal product code
    Other name
    D-penicillamine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient will receive its individual daily dose , given as twice daily

    Arm title
    		 Trientine tetrahydrochloride arm
    Arm description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl
    Arm type
    		 Experimental

    Investigational medicinal product name
    TETA 4HCl
    Investigational medicinal product code
    Other name
    trientine tetrahydrochloride, Cuprior
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The total daily dose in milligrams of trientine base was the same total daily dose in milligrams of penicillamine administered at the end of the Penicillamine Baseline Period at Week 12, rounded to the nearest 150 mg of trientine base. Each patient will receive its individual daily dose, given as twice daily

    Number of subjects in period 3
    		Penicillamine arm Trientine tetrahydrochloride arm
    Started
    26
    26
    Completed
    19
    23
    Not completed
    7
    3
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    1
    1
         Other: not further specified
    3
    1
    Period 4
    Period 4 title
    2nd Extension phase W60 ≤ W108
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Penicillamine arm
    Arm description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TETA 4HCl
    Investigational medicinal product code
    Other name
    trientine tetrahydrochloride, Cuprior
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The total daily dose in milligrams of trientine base to be administered will be the same total daily dose in milligrams of penicillamine administered at the end of the Penicillamine previous Period at Week 60, rounded to the nearest 150 mg of trientine base. Each patient will receive its individual daily dose, given as twice daily

    Arm title
    		 Trientine tetrahydrochloride arm
    Arm description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl
    Arm type
    		 Experimental

    Investigational medicinal product name
    TETA 4HCl
    Investigational medicinal product code
    Other name
    trientine tetrahydrochloride, Cuprior
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient will receive its individual daily dose , given as twice daily

    Number of subjects in period 4
    		Penicillamine arm Trientine tetrahydrochloride arm
    Started
    19
    23
    Completed
    19
    21
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Screen and baseline run-in period
    Reporting group description
    		 -

    Reporting group values
    		 Screen and baseline run-in period Total
    Number of subjects
    		 77 77
    Age categorical
    Age was defined to be between 18 and 75 years (extremes included), at the time of consent
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 73 73
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.9 ± 14.50 -
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 39 39
    Subject analysis sets

    Subject analysis set title
    Penicillamine arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to Penicillamine treatment

    Subject analysis set title
    Trientine tetrahydrochloride arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to TETA 4HCl treatment

    Subject analysis sets values
    		 Penicillamine arm Trientine tetrahydrochloride arm
    Number of subjects
    27
    26
    Age categorical
    Age was defined to be between 18 and 75 years (extremes included), at the time of consent
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    51
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.6 ± 14.49
    ±
    Gender categorical
    Units: Subjects
        Female
    28
        Male
    25

    End points

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    End points reporting groups
    Reporting group title
    Screen and run-in failures
    Reporting group description
    		 All subject that were screened, and failed to meet the enrolment criteria between screening and randomization
    Reporting group title
    Penicillamine arm
    Reporting group description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl

    Reporting group title
    Trientine tetrahydrochloride arm
    Reporting group description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl
    Reporting group title
    Penicillamine arm
    Reporting group description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl

    Reporting group title
    Trientine tetrahydrochloride arm
    Reporting group description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl
    Reporting group title
    Penicillamine arm
    Reporting group description
    		 All patients in the penicillamine arm will receive following treatments: Period 1: penicillamine Period 2: penicillamine Period 3: penicillamine Period 4: TETA 4HCl

    Reporting group title
    Trientine tetrahydrochloride arm
    Reporting group description
    		 All patients in the trientine tetrahydrochloride arm will receive following treatments: Period 1: penicillamine Period 2: TETA 4HCl Period 3: TETA 4HCl Period 4: TETA 4HCl

    Subject analysis set title
    Penicillamine arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to Penicillamine treatment

    Subject analysis set title
    Trientine tetrahydrochloride arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized to TETA 4HCl treatment

    Primary: Serum Non-ceruloplasmin bound copper (NCC) concentration

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    End point title
    		 Serum Non-ceruloplasmin bound copper (NCC) concentration
    End point description
    Summary statistics
    End point type
    Primary
    End point timeframe
    Week 36
    End point values
    		 Penicillamine arm Trientine tetrahydrochloride arm
    Number of subjects analysed
    25
    26
    Units: µg/L
        arithmetic mean (standard deviation)
    46.5 ± 5.69
    58.7 ± 5.54
    Statistical analysis title
    		 Serum NCC Concentration
    Statistical analysis description
    The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36
    Comparison groups
    Penicillamine arm v Trientine tetrahydrochloride arm
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -50
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.49
    Notes
    [1] - The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed up to week 36 using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a noninferiority margin of 50 μg/L was used

    Secondary: 24-hour Urinary Copper Excretion (UCE)

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    End point title
    		 24-hour Urinary Copper Excretion (UCE)
    End point description
    24-hour urinary copper excretion (μg/ 24 hr) from urine collected by the patient over a 24-hour period, at week 12 (end of Baseline) and at week 36 (end of period 2, post randomization)
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Penicillamine arm Trientine tetrahydrochloride arm
    Number of subjects analysed
    27
    26
    Units: μg/24 hours
        arithmetic mean (standard deviation)
    510.8 ± 47.77
    274.5 ± 45.59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    To allow for a direct comparission between treatments, only treatment emergent adverse events from week 12 to 36 and from week 36 to 60 are reported.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Penicillamine arm (W12-36)
    Reporting group description
    		 WD patients that were adequately controlled and tolerating penicillamine at the end of the baseline period and being randomized to the penicillamine arm to continue in the 24 week post randomization phase (period 1) on penicillamine. Only (S)AEs reported during the 24 post randomization phase are reflected

    Reporting group title
    TETA 4HCl arm (W12-36)
    Reporting group description
    		 WD patients that were adequately controlled and tolerating penicillamine at the end of the baseline period and being randomized to the TETA 4HCl arm to continue in the 24 week post randomization phase (period 1) on TETA 4HCl. Only (S)AEs reported during the 24 post randomization phase are reflected

    Reporting group title
    Penicillamine arm (W36-60)
    Reporting group description
    		 WD patients that were adequately controlled and tolerating penicillamine at the end of the 24 week post randomization phase (period 1) on penicillamine continued on the same treatment in the 1st extension after the post randomization phase (period 1), i.e., penicillamine. Only (S)AEs reported during the 1st extension (W36-60) are reflected

    Reporting group title
    TETA 4HCl arm (W36-60)
    Reporting group description
    		 WD patients that were adequately controlled and tolerating TETA 4HCl at the end of the 24 week post randomization phase (period 1) continued on the same treatment in the 1st extension after the post randomization phase (period 1), i.e., TETA 4HCl. Only (S)AEs reported during the 1st extension (W36-60) are reflected.

    Serious adverse events
    		 Penicillamine arm (W12-36) TETA 4HCl arm (W12-36) Penicillamine arm (W36-60) TETA 4HCl arm (W36-60)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholangiocarcinoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Penicillamine arm (W12-36) TETA 4HCl arm (W12-36) Penicillamine arm (W36-60) TETA 4HCl arm (W36-60)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 27 (33.33%)
    6 / 26 (23.08%)
    3 / 24 (12.50%)
    1 / 25 (4.00%)
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 27 (18.52%)
    2 / 26 (7.69%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences all number
    8
    4
    1
    0
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 26 (15.38%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    12
    0
    0
    Abnormal faeces
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Dry mouth
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Renal and urinary disorders
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
    2 / 24 (8.33%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    2
    1
    Psychiatric disorders
    Mood swings
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 26 (3.85%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Infections and infestations
    Gastroenteritis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    0

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36183738
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