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    Clinical Trial Results:
    Telaprevir in patients with genotype 3 HCV : pilot clinical study to evaluate efficacy and predictability of therapy in patients who have failed to respond to pegylated interferon and ribavirin

    Summary
    EudraCT number
    2013-003729-27
    Trial protocol
    GB  
    Global end of trial date
    02 Nov 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Dec 2017
    First version publication date
    09 Dec 2017
    Other versions
    Summary report(s)
    TIG3 summary

    Trial information

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    Trial identification
    Sponsor protocol code
    0.8
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02087111
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Graham Foster: PI
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Foster, Queen Marys School of Medicine, 0044 0207 882 7242, g.r.foster@qmul.ac.uk
    Scientific contact
    Foster, Queen Marys School of Medicine, 0044 207 882 7242, g.r.foster@qmul.ac.uk
    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
    02 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Do patients with genotype 3 hepatitis C and cirrhosis who have failed to respond to pegylated interferon and ribavirin respond to retreatment with pegylated interferon, ribavirin and telaprevir? Does pre-treatment viral phenotyping identify patients who respond to pegylated interferon, ribavirin and telaprevir?
    Protection of trial subjects
    An independent monitoring committee monitored the study and reviewed patient safety
    Background therapy
    The patient population studied (Genotype 3 with cirrhosis who had failed standard therapy) had no treatment options available and therefore there was no comparator or background therapy
    Evidence for comparator
    Not required, there was no comparator
    Actual start date of recruitment
    03 Jun 2013
    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
    United Kingdom: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment from 4 July 2014 to 6 November 2014. Recruitment took place in four English centres - Barts Health, London, St Georges Hospital, London, Bradford Royal Infirmary and Nottingham University Hospital

    Pre-assignment
    Screening details
    Patients with genotype 3 HCV and cirrhosis who had failed to respond to therapy with pegylated interferon and ribavirin were screened for the study.

    Pre-assignment period milestones
    Number of subjects started
    14
    Number of subjects completed
    14

    Period 1
    Period 1 title
    Enrollment
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Active arm
    Arm description
    Active arm
    Arm type
    Experimental

    Investigational medicinal product name
    Pegasys (Pegylated interferon-alfa 2a)
    Investigational medicinal product code
    ATC code = L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms once a week given as a subcutaneous injection

    Investigational medicinal product name
    Ribavirin (Copegus)
    Investigational medicinal product code
    ATC code = J05AB04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered twice a day, total dose 800mg

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    MA code EU/1/11/720/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1125mg administered twice a day

    Number of subjects in period 1
    Active arm
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Post 4 week therapy
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Active arm
    Arm description
    Active arm
    Arm type
    Experimental

    Investigational medicinal product name
    Pegasys (Pegylated interferon-alfa 2a)
    Investigational medicinal product code
    ATC code = L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms once a week given as a subcutaneous injection

    Investigational medicinal product name
    Ribavirin (Copegus)
    Investigational medicinal product code
    ATC code = J05AB04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered twice a day, total dose 800mg

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    MA code EU/1/11/720/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1125mg administered twice a day

    Number of subjects in period 2
    Active arm
    Started
    14
    Completed
    10
    Not completed
    4
         Lack of efficacy
             3
         Consent withdrawn by subject
             1
    Period 3
    Period 3 title
    End of therapy
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Active arm
    Arm description
    Active arm
    Arm type
    Experimental

    Investigational medicinal product name
    Pegasys (Pegylated interferon-alfa 2a)
    Investigational medicinal product code
    ATC code = L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms once a week given as a subcutaneous injection

    Investigational medicinal product name
    Ribavirin (Copegus)
    Investigational medicinal product code
    ATC code = J05AB04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered twice a day, total dose 800mg

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    MA code EU/1/11/720/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1125mg administered twice a day

    Number of subjects in period 3
    Active arm
    Started
    10
    Completed
    9
    Not completed
    1
         Lack of efficacy
             1
    Period 4
    Period 4 title
    SVR
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Active arm
    Arm description
    Active arm
    Arm type
    Experimental

    Investigational medicinal product name
    Pegasys (Pegylated interferon-alfa 2a)
    Investigational medicinal product code
    ATC code = L03AB11
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms once a week given as a subcutaneous injection

    Investigational medicinal product name
    Ribavirin (Copegus)
    Investigational medicinal product code
    ATC code = J05AB04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered twice a day, total dose 800mg

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    MA code EU/1/11/720/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1125mg administered twice a day

    Number of subjects in period 4
    Active arm
    Started
    9
    Completed
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active arm
    Reporting group description
    Active arm

    Reporting group values
    Active arm Total
    Number of subjects
    14 14
    Age categorical
    Characteristics of patients
    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)
    14 14
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    47 (32 to 63) -
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    10 10
    Ethnic group
    Ethnicity
    Units: Subjects
        Caucasian
    6 6
        Asian
    7 7
        Other
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Active arm
    Reporting group description
    Active arm
    Reporting group title
    Active arm
    Reporting group description
    Active arm
    Reporting group title
    Active arm
    Reporting group description
    Active arm
    Reporting group title
    Active arm
    Reporting group description
    Active arm

    Subject analysis set title
    SVR rate
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Patients who achieved a sustained virological response

    Primary: Sustained virological response

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    End point title
    Sustained virological response [1]
    End point description
    Sustained virological response
    End point type
    Primary
    End point timeframe
    Post therapy
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The trial was discontinued before an adequate number of patients had been recruited. The trial was terminated because new drugs had been licensed rendering this therapy inappropriate. The steering committee deemed it unethical to continue the trial. Analysis of 14 patients is clearly inappropriate
    End point values
    Active arm
    Number of subjects analysed
    9
    Units: Individuals
        SVR
    4
    No statistical analyses for this end point

    Other pre-specified: Virological response after 4 weeks

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    End point title
    Virological response after 4 weeks
    End point description
    Number responding after 4 weeks
    End point type
    Other pre-specified
    End point timeframe
    4 weeks after therapy initiated
    End point values
    Active arm
    Number of subjects analysed
    14
    Units: Individuals
        EVR
    10
    No statistical analyses for this end point

    Other pre-specified: End of therapy response

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    End point title
    End of therapy response
    End point description
    End of therapy response
    End point type
    Other pre-specified
    End point timeframe
    End of therapy
    End point values
    Active arm
    Number of subjects analysed
    10
    Units: Individuals
        ETR
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Trial commencement until completion of results analysis - specifically 2 June 2013 to 8 September 2017
    Adverse event reporting additional description
    All patients developed at least one adverse event.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    1.36.4
    Reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    Contains all patients in the trial

    Serious adverse events
    Treatment arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Blood and lymphatic system disorders
    Thrombocytopaenia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Insomnia
         subjects affected / exposed
    6 / 14 (42.86%)
         occurrences all number
    6
    Dizzyness
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Paresthesiae
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Memory impairment
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Visual disturbance
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Dysguesia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 14 (50.00%)
         occurrences all number
    7
    Pyrexia
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Proctalgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 14 (64.29%)
         occurrences all number
    10
    Vomiting
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Loss of appetite
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Dyspepsia
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Rectal bleeding
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dental abscess
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sore mouth
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Psychiatric disorders
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Weakness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Anxiety disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hepatobiliary disorders
    Elevated GGT
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Elevated bilirubin
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal discomfort
         subjects affected / exposed [1]
    1 / 4 (25.00%)
         occurrences all number
    1
    Vaginal candidiasis
         subjects affected / exposed [2]
    1 / 4 (25.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    11 / 14 (78.57%)
         occurrences all number
    21
    Pruritis
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Periorbital oedema
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hair loss
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Injection site reaction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Generalised pain
         subjects affected / exposed
    5 / 14 (35.71%)
         occurrences all number
    5
    Lower limb pain
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Foot injury
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only women or transgenders are capable of suffering vaginal symptoms
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only women or transgenders are capable of suffering vaginal symptoms

    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.
    During the trial an alternative treatment option for these patients was licensed and made available by NHSE and given the superiority of the newly licensed therapy it was deemed unethical to continue the study which was therefore stopped prematurely
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