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    Clinical Trial Results:
    EXTEND: A 3-Year, Virology, Follow-up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

    Summary
    EudraCT number
    2009-011464-11
    Trial protocol
    DE   FR  
    Global end of trial date
    23 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VX08-950-112
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00916474
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Boston, MA, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.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 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cohort A: To assess the durability of virologic response in subjects who achieved a sustained viral response (SVR) following telaprevir-based treatment in a previous study. Cohort B: To evaluate changes in hepatitis C virus (HCV) variants over time in subjects who did not achieve an SVR following telaprevir-based treatment in a previous study.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jun 2009
    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
    Austria: 12
    Country: Number of subjects enrolled
    France: 50
    Country: Number of subjects enrolled
    Germany: 58
    Country: Number of subjects enrolled
    Canada: 30
    Country: Number of subjects enrolled
    Puerto Rico: 4
    Country: Number of subjects enrolled
    United States: 254
    Worldwide total number of subjects
    408
    EEA total number of subjects
    120
    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)
    387
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects previously treated with at least 1 dose of telaprevir-based treatment in 1 of the following studies were enrolled: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216 (referred as Studies 104, 104EU, 106, 107, 108, 111, and C216).

    Pre-assignment
    Screening details
    All subjects were divided into 2 cohorts: Cohort A: Subjects who achieved an SVR in the previous telaprevir study and Cohort B: Subjects who did not achieve SVR in the previous telaprevir study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort A – Subjects with SVR
    Arm description
    Subjects who received at least 1 dose of telaprevir-based treatment and achieved an SVR in the previous telaprevir study.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir administered in previous study.

    Arm title
    Cohort B – Subjects without SVR
    Arm description
    Subjects who received at least 1 dose of telaprevir-based treatment and who did not achieve an SVR in the previous telaprevir study.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir administered in previous study.

    Number of subjects in period 1
    Cohort A – Subjects with SVR Cohort B – Subjects without SVR
    Started
    220
    188
    Completed
    172
    110
    Not completed
    48
    78
         Study Terminated by Sponsor
    -
    1
         Death
    4
    2
         Unspecified
    1
    4
         Consent withdrawn by subject
    9
    13
         Received Investigational Treatment for HCV
    -
    10
         Plan to Receive Investigational Treatment for HCV
    -
    23
         Lost to follow-up
    34
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A – Subjects with SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and achieved an SVR in the previous telaprevir study.

    Reporting group title
    Cohort B – Subjects without SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and who did not achieve an SVR in the previous telaprevir study.

    Reporting group values
    Cohort A – Subjects with SVR Cohort B – Subjects without SVR Total
    Number of subjects
    220 188 408
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.3 ± 8.08 53.8 ± 7.21 -
    Gender categorical
    Units: Subjects
        Female
    68 56 124
        Male
    152 132 284

    End points

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    End points reporting groups
    Reporting group title
    Cohort A – Subjects with SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and achieved an SVR in the previous telaprevir study.

    Reporting group title
    Cohort B – Subjects without SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and who did not achieve an SVR in the previous telaprevir study.

    Primary: Cohort A: Percentage of Subjects Who Maintained Undetectable HCV RNA Over Time After Achieving SVR

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    End point title
    Cohort A: Percentage of Subjects Who Maintained Undetectable HCV RNA Over Time After Achieving SVR [1] [2]
    End point description
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification (LLOQ) was 25 IU/mL and lower limit of detection was 10 international units per milliliter (IU/mL). Analysis was performed on the Efficacy Set defined as all subjects who were enrolled per entry criteria.
    End point type
    Primary
    End point timeframe
    36 months
    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: No inferential statistics was planned.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applicable for Cohort A only.
    End point values
    Cohort A – Subjects with SVR
    Number of subjects analysed
    220
    Units: percentage of subjects
        number (not applicable)
    100
    No statistical analyses for this end point

    Primary: Cohort B: Percentage of Subjects With Change of Resistant Mutation to Wild Type From Previous Study

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    End point title
    Cohort B: Percentage of Subjects With Change of Resistant Mutation to Wild Type From Previous Study [3] [4]
    End point description
    Sequencing analyses were conducted on samples with total HCV RNA levels above the limit of detection of the sequencing assay (1000 IU/mL). A subject’s HCV population was considered to have changed to WT if a WT AA character was observed at all 6 resistance-associated mutation (RAM) positions in the subject’s viral sequencing data. Analysis was performed on Evaluable for Resistance Profile Virology Population defined as all subjects who had resistant profile at baseline in previous study, had non-resistant profile at post-nadir visit, or lacked sequencing data after post-nadir visit.
    End point type
    Primary
    End point timeframe
    36 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applicable for Cohort B only.
    End point values
    Cohort B – Subjects without SVR
    Number of subjects analysed
    139 [5]
    Units: percentage of subjects
    number (not applicable)
        HCV Genotype 1a (n=110)
    81.8
        HCV Genotype 1b (n=29)
    89.7
    Notes
    [5] - n = subjects with specified resistant profile
    No statistical analyses for this end point

    Secondary: Cohort A: Percentage of Subjects With Change of Resistant Mutation to Wild Type From Previous Study Among Subjects With Late Relapse

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    End point title
    Cohort A: Percentage of Subjects With Change of Resistant Mutation to Wild Type From Previous Study Among Subjects With Late Relapse [6]
    End point description
    Late relapse was defined as having detectable HCV RNA after achieving SVR.
    End point type
    Secondary
    End point timeframe
    36 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applicable for Cohort A only.
    End point values
    Cohort A – Subjects with SVR
    Number of subjects analysed
    0 [7]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [7] - The analysis was not performed as no subject in Cohort A had late relapse.
    No statistical analyses for this end point

    Secondary: Cohort A and B: Number of Subjects With Severe Liver Related Events

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    End point title
    Cohort A and B: Number of Subjects With Severe Liver Related Events
    End point description
    Severe liver related events included decompensation events (ascites, variceal bleed, and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplant, and liver-related death. Analysis was performed on Efficacy Set.
    End point type
    Secondary
    End point timeframe
    36 Months
    End point values
    Cohort A – Subjects with SVR Cohort B – Subjects without SVR
    Number of subjects analysed
    220
    188
    Units: subjects
    number (not applicable)
        Subjects with Severe Liver related events
    1
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    36 months
    Adverse event reporting additional description
    Due to observational nature of the study only SAEs related to study procedure were planned to be collected. No other safety data was collected.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    No Dictionary Coding
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Cohort A – Subjects with SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and achieved an SVR in the previous telaprevir study.

    Reporting group title
    Cohort B – Subjects without SVR
    Reporting group description
    Subjects who received at least 1 dose of telaprevir-based treatment and who did not achieve an SVR in the previous telaprevir study.

    Serious adverse events
    Cohort A – Subjects with SVR Cohort B – Subjects without SVR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 188 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cohort A – Subjects with SVR Cohort B – Subjects without SVR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 220 (0.00%)
    0 / 188 (0.00%)
    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: Due to observational nature of the study only SAEs related to study procedure were planned to be collected. No other safety data was collected.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2009
    subjects who had been retreated with an approved treatment for HCV were allowed to continue in this study and a new secondary objective to evaluate the incidence of clinical outcomes related to severe liver disease was added and sample sizes were reduced for Cohorts A and B.

    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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