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    Clinical Trial Results:
    A phase III, randomised, open label, active-controlled study of an interferon-free regimen of BI 207127 in combination with Faldaprevir and Ribavirin compared to Telaprevir in combination with pegylated interferon-a and ribavirin in treatment-naive patients with chronic genotype 1b Hepatitis C Virus infection.

    Summary
    EudraCT number
    		 2012-004544-30
    Trial protocol
    		 BE   SE   NO   IT   GB   ES   DE   DK   FR  
    Global end of trial date
    08 Apr 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2018
    First version publication date
    08 Jul 2018
    Other versions
    Summary report(s)
    		 Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    1241.37
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.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
    08 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to determine if BI207127 + Faldaprevir + Ribavirin for 24 weeks is non-inferior to treatment with telaprevir for 12 weeks + Ribavirin and Pegylated interferon for 24 or 48 weeks.
    Protection of trial subjects
    No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 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
    Norway: 99999
    Country: Number of subjects enrolled
    Spain: 99999
    Country: Number of subjects enrolled
    Belgium: 99999
    Worldwide total number of subjects
    299997
    EEA total number of subjects
    299997
    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)
    99999
    From 65 to 84 years
    99999
    85 years and over
    99999

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    		 All subjects had to be screened for eligibility to participate in the trial. Subjects had to attend specialist sites which would then ensure that they (the subjects) met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Treatment assignment is blinded to the Investigator until after the patient has committed to participation. Upon randomization, the Investigator and patient will be made aware of the open label treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Faldaprevir
    Arm description
    		 Patients were to be administered Soft gelatin capsule of Faldaprevir (First day 240 mg, then 120 mg) once daily for 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    First day 240 mg, then 120 mg once daily for 16 weeks

    Arm title
    		 BI 207127
    Arm description
    		 Patients were administered Film-coated tablets of BI 207127 (1200 mg (600mg twice daily (BID))) for 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 207127
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (1200 mg (600mg twice daily (BID))) for 16 weeks

    Arm title
    		 Telaprevir tablets
    Arm description
    		 Patients were administered Film-coated tablet 375 mg twice a day (3 tablets every 12 hours) for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Telaprevir (Incivo®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    375 mg Twice a day (3 tablets every 12 hours) for 12 weeks

    Number of subjects in period 1
    		Faldaprevir BI 207127 Telaprevir tablets
    Started
    99999
    99999
    99999
    Completed
    99999
    99999
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Faldaprevir
    Reporting group description
    		 Patients were to be administered Soft gelatin capsule of Faldaprevir (First day 240 mg, then 120 mg) once daily for 16 weeks

    Reporting group title
    BI 207127
    Reporting group description
    		 Patients were administered Film-coated tablets of BI 207127 (1200 mg (600mg twice daily (BID))) for 16 weeks

    Reporting group title
    Telaprevir tablets
    Reporting group description
    		 Patients were administered Film-coated tablet 375 mg twice a day (3 tablets every 12 hours) for 12 weeks.

    Reporting group values
    		 Faldaprevir BI 207127 Telaprevir tablets Total
    Number of subjects
    		 99999 99999 99999 299997
    Age categorical
    Units: Subjects
    Age continuous
    Discontinued by Boehringer Ingelheim during preparation of trial. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 0 ( 0 ) -
    Gender categorical
    Discontinued by Boehringer Ingelheim during preparation of trial. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    Units: Subjects
        Female
    		 99999 99999 99999 299997
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Faldaprevir
    Reporting group description
    		 Patients were to be administered Soft gelatin capsule of Faldaprevir (First day 240 mg, then 120 mg) once daily for 16 weeks

    Reporting group title
    BI 207127
    Reporting group description
    		 Patients were administered Film-coated tablets of BI 207127 (1200 mg (600mg twice daily (BID))) for 16 weeks

    Reporting group title
    Telaprevir tablets
    Reporting group description
    		 Patients were administered Film-coated tablet 375 mg twice a day (3 tablets every 12 hours) for 12 weeks.

    Primary: Sustained Virological response (SVR) at Week 12 post-treatment (SVR12)

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    End point title
    		 Sustained Virological response (SVR) at Week 12 post-treatment (SVR12) [1]
    End point description
    SVR at Week 12 post-treatment (SVR12): Plasma HCV RNA level <25 IU/mL at 12 weeks after End of Treatment (EOT) Discontinued by Boehringer Ingelheim during preparation of trial. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    Week 12
    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 subjects were enrolled in the trial hence results are not available
    End point values
    		 Faldaprevir BI 207127 Telaprevir tablets
    Number of subjects analysed
    99999 [2]
    99999 [3]
    99999 [4]
    Units: percentage of participants
    99999
    99999
    99999
    Notes
    [2] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [3] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [4] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    No statistical analyses for this end point

    Secondary: SVR at Week 4 post-treatment (SVR4):

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    End point title
    		 SVR at Week 4 post-treatment (SVR4):
    End point description
    SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Faldaprevir BI 207127 Telaprevir tablets
    Number of subjects analysed
    99999 [5]
    99999 [6]
    99999 [7]
    Units: percentage of participants
    99999
    99999
    99999
    Notes
    [5] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [6] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [7] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    No statistical analyses for this end point

    Secondary: SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.

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    End point title
    		 SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
    End point description
    SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Faldaprevir BI 207127 Telaprevir tablets
    Number of subjects analysed
    99999 [8]
    99999 [9]
    99999 [10]
    Units: percentage of participants
    99999
    99999
    99999
    Notes
    [8] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [9] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [10] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    No statistical analyses for this end point

    Secondary: Adverse Events (AEs), Serious Adverse Events (SAEs), lab values

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    End point title
    		 Adverse Events (AEs), Serious Adverse Events (SAEs), lab values
    End point description
    Adverse Events (AEs), Serious Adverse Events (SAEs), lab values. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Secondary
    End point timeframe
    All adverse events, serious and non-serious, with an onset date from signing the informed consent up to follow up visit (28 days after all treatment discontinuation); up to 52 weeks
    End point values
    		 Faldaprevir BI 207127 Telaprevir tablets
    Number of subjects analysed
    99999 [11]
    99999 [12]
    99999 [13]
    Units: percentage of participants
    99999
    99999
    99999
    Notes
    [11] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [12] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    [13] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events, serious and non-serious, with an onset date from signing the informed consent up to follow up visit (28 days after all treatment discontinuation); up to 52 weeks
    Adverse event reporting additional description
    No patient entered the study, therefore no results data available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trial hence results are not available

    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.
    Discontinued by Boehringer Ingelheim during initiation of the trial. No patient entered the study, therefore no results / data are available.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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