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    Clinical Trial Results:
    Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Geno type 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2011-004928-35
    Trial protocol
    SE   GB   ES   PL  
    Global end of trial date
    03 Jun 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    02 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    VX-950HPC3008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01513941
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, 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
    03 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the antiviral efficacy of telaprevir, pegylated interferon (Peg-IFN)-alfa-2a, and ribavirin (RBV) in hepatitis C virus genotype 1 (HCV-1)/human immunodeficiency virus type 1 (HIV-1)-coinfected subjects as measured by sustained virologic response (SVR12planned), defined as having plasma HCV ribonucleic acid (RNA) levels <25 IU/mL 12 weeks after the last planned dose of HCV study drugs.
    Protection of trial subjects
    The safety assessments included Adverse events (AEs), Electrocardiogram (ECG) data, Clinical laboratory tests, Hematology, Coagulation Panel, Biochemistry, Urinalysis, Pregnancy tests and vital signs were monitored throughout the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Mar 2012
    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
    Spain: 48
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    Brazil: 29
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Russian Federation: 20
    Worldwide total number of subjects
    162
    EEA total number of subjects
    102
    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)
    160
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Up to 263 Participants were Screened into the study. Of these, 162 participants were treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment Naive
    Arm description
    Participants taking one of the permitted HAART regimens for HIV and HCV treatment-naïve defined as subjects who had not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C.
    Arm type
    Experimental

    Investigational medicinal product name
    Incivo
    Investigational medicinal product code
    Other name
    Telaprevir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 750 milligram [mg] every 8 hours [q8h], up to week 12 or if the HAART regimen was Efavirenz-based 1125 mg q8h for 12 weeks of film-coated tablet for oral administration.

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Peg-IFN-alfa-2a
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 180-microgram (μg) solution for subcutaneous injection in a prefilled syringe per week up to 48 weeks.

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    ribavirin (RBV)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 800 milligram per Day (mg/day) up to 48 weeks of film-coated tablet for oral administration.

    Arm title
    Treatment Experienced
    Arm description
    Participants taking one of the permitted HAART regimens for HIV and HCV-treatment -experienced defined as presence of prior treatment with Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus (HCV).
    Arm type
    Experimental

    Investigational medicinal product name
    Incivo
    Investigational medicinal product code
    Other name
    Telaprevir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 750 milligram [mg] every 8 hours [q8h], up to week 12 or if the HAART regimen was Efavirenz-based 1125 mg q8h for 12 weeks of film-coated tablet for oral administration.

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Peg-IFN-alfa-2a
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 180-microgram (μg) solution for subcutaneous injection in a prefilled syringe per week up to 48 weeks.

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    Ribavirin (RBV)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 800 milligram per Day (mg/day) up to 48 weeks of film-coated tablet for oral administration.

    Number of subjects in period 1
    Treatment Naive Treatment Experienced
    Started
    64
    98
    Completed
    53
    81
    Not completed
    11
    17
         Other
    2
    5
         Adverse event, non-fatal
    1
    -
         Consent withdrawn by subject
    3
    9
         Lost to follow-up
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Naive
    Reporting group description
    Participants taking one of the permitted HAART regimens for HIV and HCV treatment-naïve defined as subjects who had not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C.

    Reporting group title
    Treatment Experienced
    Reporting group description
    Participants taking one of the permitted HAART regimens for HIV and HCV-treatment -experienced defined as presence of prior treatment with Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus (HCV).

    Reporting group values
    Treatment Naive Treatment Experienced Total
    Number of subjects
    64 98 162
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    63 97 160
        From 65 to 84 years
    1 1 2
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    42.1 ± 8.64 46.9 ± 7.96 -
    Title for Gender
    Units: subjects
        Female
    13 22 35
        Male
    51 76 127

    End points

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    End points reporting groups
    Reporting group title
    Treatment Naive
    Reporting group description
    Participants taking one of the permitted HAART regimens for HIV and HCV treatment-naïve defined as subjects who had not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C.

    Reporting group title
    Treatment Experienced
    Reporting group description
    Participants taking one of the permitted HAART regimens for HIV and HCV-treatment -experienced defined as presence of prior treatment with Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus (HCV).

    Subject analysis set title
    Prior Relapsers
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants had undetectable HCV RNA at the end of previous treatment (between 8 weeks prior to and 6 weeks after the last dose of HCV medication) but had not achieved sustained virologic response (SVR).

    Subject analysis set title
    Prior Non-responders
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subject failed to have decrease in hepatitis C virus (HCV) ribonucleic acid (RNA) by greater than (>) 2 log10 after approximately 12 weeks of previous HCV therapy

    Primary: Percentage of participants achieving sustained virologic response (SVR) 12 planned

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    End point title
    Percentage of participants achieving sustained virologic response (SVR) 12 planned [1]
    End point description
    Sustained virologic response (SVR) planned defined as having plasma HCV RNA levels <25 IU/mL 12 weeks after the last planned dose of HCV study drugs.
    End point type
    Primary
    End point timeframe
    60 weeks
    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
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (confidence interval 95%)
    64.1 (51.1 to 75.7)
    53.1 (42.7 to 63.2)
    62.1 (42.3 to 79.3)
    49.3 (37 to 61.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Extended Rapid Virologic Response (eRVR)

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    End point title
    Percentage of Participants with Extended Rapid Virologic Response (eRVR)
    End point description
    Extended Rapid Virologic Response (eRVR) is defined as having plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels Less than (<) 25 IU/mL, target not detected at Week 4 and Week 12 of treatment.
    End point type
    Secondary
    End point timeframe
    Week 4 and week 12
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (confidence interval 95%)
    57.8 (44.8 to 70.1)
    43.9 (33.9 to 54.3)
    48.3 (29.4 to 67.5)
    42 (30.2 to 54.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Relapse

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    End point title
    Percentage of Participants with Relapse
    End point description
    Relapse having confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) from planned end of treatment (i.e., Week 24 or Week 48) onwards after previous HCV RNA <25 IU/mL at planned end of HCV treatment, and not achieving sustained virologic response rates 12 weeks after the last (planned) dose of HCV study drugs (SVR12 planned).
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 60
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    45
    56
    19
    37
    Units: Percentage
        number (not applicable)
    8.9
    7.1
    5.3
    8.1
    No statistical analyses for this end point

    Secondary: Number of participants with viral breakthrough

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    End point title
    Number of participants with viral breakthrough
    End point description
    Viral breakthrough was defined as having a confirmed increase greater than (>) 1 log10 in hepatitis C virus (HCV) RNA level from the lowest level reached during a considered treatment phase or a confirmed value of hepatitis C virus (HCV) ribonucleic acid(RNA) greater than (>) 100 international unit per millilitre (IU/mL) in participants whose hepatitis C virus (HCV) ribonucleic acid (RNA) level had previously become greater than (>) 25 international unit per millilitre (IU/mL) during the considered treatment phase.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 1) up to Week 24/48
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (not applicable)
    14.1
    18.4
    3.4
    24.6
    No statistical analyses for this end point

    Secondary: Number of participants achieving sustained virologic response (SVR) 24 planned

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    End point title
    Number of participants achieving sustained virologic response (SVR) 24 planned
    End point description
    SVR24planned, defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per millilitre (IU/mL) 24 weeks after the last planned dose of HCV study drugs.
    End point type
    Secondary
    End point timeframe
    72 weeks
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (not applicable)
    64.1
    54.1
    65.5
    49.3
    No statistical analyses for this end point

    Secondary: Percentage of participants having plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels less than (<) 25 international unit per mililitre (IU/mL), target not detected at the planned end of treatment

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    End point title
    Percentage of participants having plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels less than (<) 25 international unit per mililitre (IU/mL), target not detected at the planned end of treatment
    End point description
    Proportion of participants having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (not applicable)
    79.7
    70.4
    91.3
    62.1
    No statistical analyses for this end point

    Secondary: Participants with on-treatment virologic failure

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    End point title
    Participants with on-treatment virologic failure
    End point description
    Virologic failure (ie, Participants who met a virologic stopping rule and/or met the definition of viral breakthrough).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 1) up to Week 24/48
    End point values
    Treatment Naive Treatment Experienced Prior Relapsers Prior Non-responders
    Number of subjects analysed
    64
    98
    29
    69
    Units: Percentage
        number (not applicable)
    21.9
    27.6
    3.4
    37.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Upto 4 weeks after the last intake of hepatitis C virus (HCV) study drugs.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    TREATMENT NAIVE
    Reporting group description
    Subjects who were not given treatment previously.

    Reporting group title
    TREATMENT EXPERIENCED
    Reporting group description
    Subjects who were given treatment previously.

    Serious adverse events
    TREATMENT NAIVE TREATMENT EXPERIENCED
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 64 (15.63%)
    12 / 98 (12.24%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate Cancer Metastatic
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Right
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infiltration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary Colic
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    TREATMENT NAIVE TREATMENT EXPERIENCED
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 64 (96.88%)
    93 / 98 (94.90%)
    Investigations
    Weight Decreased
         subjects affected / exposed
    6 / 64 (9.38%)
    7 / 98 (7.14%)
         occurrences all number
    8
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 64 (7.81%)
    7 / 98 (7.14%)
         occurrences all number
    5
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 64 (17.19%)
    19 / 98 (19.39%)
         occurrences all number
    22
    32
    Leukopenia
         subjects affected / exposed
    4 / 64 (6.25%)
    3 / 98 (3.06%)
         occurrences all number
    10
    6
    Neutropenia
         subjects affected / exposed
    9 / 64 (14.06%)
    15 / 98 (15.31%)
         occurrences all number
    17
    36
    Thrombocytopenia
         subjects affected / exposed
    8 / 64 (12.50%)
    19 / 98 (19.39%)
         occurrences all number
    12
    34
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    5 / 64 (7.81%)
    5 / 98 (5.10%)
         occurrences all number
    5
    5
    Dizziness
         subjects affected / exposed
    5 / 64 (7.81%)
    5 / 98 (5.10%)
         occurrences all number
    6
    5
    Headache
         subjects affected / exposed
    15 / 64 (23.44%)
    17 / 98 (17.35%)
         occurrences all number
    23
    18
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 64 (18.75%)
    22 / 98 (22.45%)
         occurrences all number
    14
    26
    Influenza Like Illness
         subjects affected / exposed
    13 / 64 (20.31%)
    28 / 98 (28.57%)
         occurrences all number
    18
    32
    Fatigue
         subjects affected / exposed
    25 / 64 (39.06%)
    21 / 98 (21.43%)
         occurrences all number
    29
    23
    Irritability
         subjects affected / exposed
    13 / 64 (20.31%)
    9 / 98 (9.18%)
         occurrences all number
    14
    9
    Pyrexia
         subjects affected / exposed
    12 / 64 (18.75%)
    13 / 98 (13.27%)
         occurrences all number
    16
    17
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 64 (3.13%)
    10 / 98 (10.20%)
         occurrences all number
    2
    11
    Depressed Mood
         subjects affected / exposed
    4 / 64 (6.25%)
    5 / 98 (5.10%)
         occurrences all number
    4
    6
    Depression
         subjects affected / exposed
    7 / 64 (10.94%)
    9 / 98 (9.18%)
         occurrences all number
    8
    9
    Insomnia
         subjects affected / exposed
    14 / 64 (21.88%)
    19 / 98 (19.39%)
         occurrences all number
    16
    27
    Sleep Disorder
         subjects affected / exposed
    2 / 64 (3.13%)
    7 / 98 (7.14%)
         occurrences all number
    2
    7
    Gastrointestinal disorders
    Anal Pruritus
         subjects affected / exposed
    15 / 64 (23.44%)
    13 / 98 (13.27%)
         occurrences all number
    15
    18
    Anorectal Discomfort
         subjects affected / exposed
    2 / 64 (3.13%)
    6 / 98 (6.12%)
         occurrences all number
    2
    8
    Diarrhoea
         subjects affected / exposed
    15 / 64 (23.44%)
    14 / 98 (14.29%)
         occurrences all number
    25
    17
    Dry Mouth
         subjects affected / exposed
    5 / 64 (7.81%)
    4 / 98 (4.08%)
         occurrences all number
    5
    4
    Dyspepsia
         subjects affected / exposed
    2 / 64 (3.13%)
    7 / 98 (7.14%)
         occurrences all number
    2
    8
    Nausea
         subjects affected / exposed
    16 / 64 (25.00%)
    17 / 98 (17.35%)
         occurrences all number
    17
    24
    Haemorrhoids
         subjects affected / exposed
    4 / 64 (6.25%)
    6 / 98 (6.12%)
         occurrences all number
    5
    7
    Vomiting
         subjects affected / exposed
    7 / 64 (10.94%)
    9 / 98 (9.18%)
         occurrences all number
    12
    11
    Proctalgia
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 98 (0.00%)
         occurrences all number
    7
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    4 / 64 (6.25%)
    7 / 98 (7.14%)
         occurrences all number
    5
    13
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 64 (6.25%)
    5 / 98 (5.10%)
         occurrences all number
    4
    7
    Dry Skin
         subjects affected / exposed
    14 / 64 (21.88%)
    9 / 98 (9.18%)
         occurrences all number
    15
    13
    Pruritus
         subjects affected / exposed
    35 / 64 (54.69%)
    41 / 98 (41.84%)
         occurrences all number
    50
    51
    Rash
         subjects affected / exposed
    20 / 64 (31.25%)
    24 / 98 (24.49%)
         occurrences all number
    23
    31
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 64 (6.25%)
    6 / 98 (6.12%)
         occurrences all number
    5
    8
    Bone Pain
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 98 (1.02%)
         occurrences all number
    4
    1
    Back Pain
         subjects affected / exposed
    1 / 64 (1.56%)
    6 / 98 (6.12%)
         occurrences all number
    1
    6
    Myalgia
         subjects affected / exposed
    14 / 64 (21.88%)
    7 / 98 (7.14%)
         occurrences all number
    14
    8
    Pain in Extremity
         subjects affected / exposed
    0 / 64 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    0
    6
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    17 / 64 (26.56%)
    9 / 98 (9.18%)
         occurrences all number
    19
    11
    Infections and infestations
    Onychomycosis
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2012
    The overall reason for the amendment was to include the following changes: To change the planned number of Participants enrolled per subgroup of the study population, To change the primary analysis` to a snaphot analysis. The snapshot analyses has been accepted by the European Medicines Agency and Food and Drug Administration for previous telaprevir Phase 3 studies and To revise some of the eligibility criteria.
    14 May 2013
    The overall reason for the amendment was to include the following changes: To revise (disallowed) concomitant drugs in line with IB Edition 14 and IB Edition 14, Addendum 2, and To clarify that switching of a highly-active antiretroviral therapy (HAART) regimen to another regimen could occur if deemed necessary by the investigator.

    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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