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    Clinical Trial Results:
    A multicenter, single-arm trial evaluating the safety and efficacy of DEB025/Alisporivir in combination with pegylated interferon-α2a and ribavirin (peg-IFNα2a/RBV) in protease inhibitor treatment failure patients with chronic hepatitis C genotype 1

    Summary
    EudraCT number
    		 2011-004653-31
    Trial protocol
    		 DE   ES   GB   IT  
    Global end of trial date
    29 May 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2016
    First version publication date
    16 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CDEB025A2306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01500772
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111 ,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111 ,
    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
    29 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy (SVR12 LOQ) of triple combination therapy of DEB025 400 mg BID and standard dose pegIFN/RBV for 48 weeks in chronic hepatitis C GT 1 patients who failed prior treatment with PI.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 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
    Germany: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The duration of screening was of 1 to 42 days, with a possibility to be extended for another 42 days. However, all patients completed screening within the first 42 days period.

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

    Arms
    Arm title
    		 DEB 400 mg BID + PEG + RBV
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025
    Investigational medicinal product code
    Other name
    lisporivir
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules (400 mg) BID for 48 weeks

    Investigational medicinal product name
    PegIFN
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 µg subcutaneous injection (s.c.) once weekly for 48 weeks

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg/day (<75 kg) or 1200 mg/day (≥75 kg) orally in two divided doses for 48 weeks

    Number of subjects in period 1
    		DEB 400 mg BID + PEG + RBV
    Started
    6
    Completed
    0
    Not completed
    6
         Early termination of the study
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    DEB 400 mg BID + PEG + RBV
    Reporting group description
    		 -

    Primary: SVR12

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    End point title
    		 SVR12 [1]
    End point description
    SVR12 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 12 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml.
    End point type
    Primary
    End point timeframe
    12 weeks after the end of treatment
    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: Due to early termination of the study, none of the planned study objectives could be evaluated.
    End point values
    		 DEB 400 mg BID + PEG + RBV
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - Due to early termination of the study, none of the planned study objectives could be evaluated.
    No statistical analyses for this end point

    Secondary: SVR24

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    End point title
    		 SVR24
    End point description
    SVR24 is defined as HCV RNA laboratory value <LOQ, (Level of quantification) 24 weeks after the end of treatment. The assay used in this study has a reported LOQ of 25 IU/ml
    End point type
    Secondary
    End point timeframe
    24 weeks after the end of treatment
    End point values
    		 DEB 400 mg BID + PEG + RBV
    Number of subjects analysed
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [3] - Due to early termination of the study, none of the planned study objectives could be evaluated.
    No statistical analyses for this end point

    Secondary: SVR12LOD

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    End point title
    		 SVR12LOD
    End point description
    SVR12LOD is defined as HCV RNA laboratory value <LOD, 12 weeks after the end of treatment. The assay used in this study as a reported LOD of 10 IU/ml.
    End point type
    Secondary
    End point timeframe
    12 weeks after the end of treatment
    End point values
    		 DEB 400 mg BID + PEG + RBV
    Number of subjects analysed
    0 [4]
    Units: percentage of participants
        number (not applicable)
    Notes
    [4] - Due to early termination of the study, none of the planned study objectives could be evaluated.
    No statistical analyses for this end point

    Secondary: Overall safety profile

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    End point title
    		 Overall safety profile
    End point description
    The evaluation the overall safety profile will be measured by proportion of patients that discontinue study drug or require dose reduction or dose interruption due to treatment-emergent AEs.
    End point type
    Secondary
    End point timeframe
    48 weeks
    End point values
    		 DEB 400 mg BID + PEG + RBV
    Number of subjects analysed
    0 [5]
    Units: percentage of participants
        number (not applicable)
    Notes
    [5] - Due to early termination of the study, none of the planned study objectives could be evaluated.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit .
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    DEB 400mg BID+PEG+RBV
    Reporting group description
    		 DEB 400mg BID+PEG+RBV

    Serious adverse events
    		 DEB 400mg BID+PEG+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (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
    		 DEB 400mg BID+PEG+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 6 (66.67%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    THROMBOCYTOPENIA
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    CHILLS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    FATIGUE
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    PYREXIA
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    DRY SKIN
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    RASH PRURITIC
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    SEBORRHOEIC DERMATITIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    SKIN FISSURES
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Psychiatric disorders
    SLEEP DISORDER
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    BONE PAIN
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    MYALGIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    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? Yes
    Date
    Interruption
    Restart date
    19 Apr 2012
    The reason for partial clinical hold was the occurrence of pancreatitis cases reported in other DEB025 trials. Seven cases of pancreatitis (including one fatal case) had been reported for patients treated with DEB025/pegIFN/RBV among approximately 1800 patients on DEB025 treatment in the phase II/III development program. Due to premature termination of the study and very limited dataset (only six patients enrolled), the planned data analyses were not performed.
    -

    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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    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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