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    Clinical Trial Results:
    A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C patients

    Summary
    EudraCT number
    		 2011-006132-24
    Trial protocol
    		 ES   HU   GB   PL   IT   DE  
    Global end of trial date
    23 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CDEB025A2313
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02465203
    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
    23 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the persistence of resistance associated variants associated with failure to previous alisporivir therapy in patients previously enrolled in three alisporivir Novartis trials who relapsed between end of treatment and twenty-four weeks later. The three trials were: CDEB025A2210, CDEB025A2211, CDEB025A2301.
    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
    03 Apr 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
    Poland: 9
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    India: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Taiwan: 17
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Vietnam: 2
    Country: Number of subjects enrolled
    Canada: 1
    Worldwide total number of subjects
    105
    EEA total number of subjects
    56
    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)
    97
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients from various Novartis studies (feeder studies) who had been treated with alisporivir and had not achieveed sustained virologic response 24 weeks after end of treatment (SVR24), i.e., treatment failure patients, entered this study. No study treatment was involved.

    Pre-assignment
    Screening details
    		 The only screening criteria was > than or equal to 18 years of age, previous participation in Novartis hepatiitis C study and failure to achieve SVR24.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients from Study 2210
    Arm description
    		 Patients from Study 2210
    Arm type
    		 Patients from Study 2210

    Investigational medicinal product name
    Alisporivir
    Investigational medicinal product code
    DEB025
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    No drug administered in this trial.

    Arm title
    		 Patients from Study 2301
    Arm description
    		 Patients from Study 2301
    Arm type
    		 Patients from Study 2301

    Investigational medicinal product name
    Alisporivir
    Investigational medicinal product code
    DEB025
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    No drug administered in this trial.

    Arm title
    		 Patients from Study 2211 Overall
    Arm description
    		 Patients from Study 2211 Overall
    Arm type
    		 Patients from Study 2211 Overall

    Investigational medicinal product name
    Alisporivir
    Investigational medicinal product code
    DEB025
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    No drug administered in this trial.

    Number of subjects in period 1
    		Patients from Study 2210 Patients from Study 2301 Patients from Study 2211 Overall
    Started
    56
    36
    13
    Completed
    0
    0
    0
    Not completed
    56
    36
    13
         Consent withdrawn by subject
    1
    1
    1
         Study terminated by sponsor
    50
    34
    11
         New therapy for study indication
    4
    -
    -
         Protocol deviation
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients from Study 2210
    Reporting group description
    		 Patients from Study 2210

    Reporting group title
    Patients from Study 2301
    Reporting group description
    		 Patients from Study 2301

    Reporting group title
    Patients from Study 2211 Overall
    Reporting group description
    		 Patients from Study 2211 Overall

    Reporting group values
    		 Patients from Study 2210 Patients from Study 2301 Patients from Study 2211 Overall Total
    Number of subjects
    		 56 36 13 105
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 51 33 13 97
        From 65-84 years
    		 5 3 0 8
    Gender categorical
    Units: Subjects
        Female
    		 23 22 4 49
        Male
    		 33 14 9 56

    End points

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    End points reporting groups
    Reporting group title
    Patients from Study 2210
    Reporting group description
    		 Patients from Study 2210

    Reporting group title
    Patients from Study 2301
    Reporting group description
    		 Patients from Study 2301

    Reporting group title
    Patients from Study 2211 Overall
    Reporting group description
    		 Patients from Study 2211 Overall

    Primary: There was no hypothesis testing in ths study.

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    End point title
    		 There was no hypothesis testing in ths study. [1]
    End point description
    There was no hypothesis testing in this study.
    End point type
    Primary
    End point timeframe
    27 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: There was no hypothesis testing in this study.
    End point values
    		 Patients from Study 2210 Patients from Study 2301 Patients from Study 2211 Overall
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: None
    Notes
    [2] - No hypothesis testing was done.
    [3] - No hypothesis testing was done.
    [4] - No hypothesis testing was done.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    From Study 2301
    Reporting group description
    		 From Study 2301

    Reporting group title
    From Study 2211 Overall
    Reporting group description
    		 From Study 2211 Overall

    Reporting group title
    From Study 2211 IFN-free
    Reporting group description
    		 From Study 2211 IFN-free

    Reporting group title
    From Study 2210
    Reporting group description
    		 From Study 2210

    Serious adverse events
    		 From Study 2301 From Study 2211 Overall From Study 2211 IFN-free From Study 2210
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    3 / 53 (5.66%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HEPATOCELLULAR CARCINOMA
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    HAND FRACTURE
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 From Study 2301 From Study 2211 Overall From Study 2211 IFN-free From Study 2210
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 33 (9.09%)
    4 / 12 (33.33%)
    2 / 6 (33.33%)
    5 / 53 (9.43%)
    Investigations
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    0
    TOTAL BILE ACIDS INCREASED
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    0
    FATIGUE
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    1
    0
    0
    2
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    HEPATIC STEATOSIS
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 12 (16.67%)
    1 / 6 (16.67%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    1
    1
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    PRURITUS
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    NECK PAIN
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
    0 / 53 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    0
    3

    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.
    Study was terminated due to change in alisporivir development program strategy. Interferon (IFN) regimen no longer of interest as an effective treatment.
    For support, Contact us.
    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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