Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in alisporivir treated chronic hepatitis C patients

    Summary
    EudraCT number
    		 2011-006131-38
    Trial protocol
    		 ES   HU   GB   PL   IT   DE  
    Global end of trial date
    22 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2016
    First version publication date
    26 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CDEB025A2312
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    22 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.
    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
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Hong Kong: 13
    Country: Number of subjects enrolled
    India: 32
    Country: Number of subjects enrolled
    Korea, Republic of: 51
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Romania: 62
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Taiwan: 76
    Country: Number of subjects enrolled
    Thailand: 76
    Country: Number of subjects enrolled
    Turkey: 14
    Country: Number of subjects enrolled
    United States: 31
    Country: Number of subjects enrolled
    Vietnam: 41
    Country: Number of subjects enrolled
    Poland: 65
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 43
    Country: Number of subjects enrolled
    Hungary: 42
    Country: Number of subjects enrolled
    Italy: 53
    Worldwide total number of subjects
    723
    EEA total number of subjects
    326
    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)
    688
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was a follow-up study where patients who achieved Sustained virologic response (SVR24) with alisporivir treatment were enrolled into this study from various Novartis studies (called feeder studies). These patients were followed up for about 2 years from last dose of study treatment, with a maximum of three visits in this study.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 From Study 2210
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Not mentioned
    Dosage and administration details
    There was no investigational treatment given to patients enrolled in this study.

    Arm title
    		 From Study 2301
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 From Study 2211 IFN-free
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 From Study 2211 Overall
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		From Study 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall
    Started
    164
    397
    54
    162
    Completed
    150
    354
    47
    139
    Not completed
    14
    43
    7
    23
         Physician decision
    1
    2
    -
    -
         Study terminated by sponsor
    -
    3
    -
    -
         Lost to follow-up
    6
    18
    4
    16
         Subject/guardian decision
    4
    3
    2
    5
         Protocol deviation
    3
    17
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    From Study 2210
    Reporting group description
    		 -

    Reporting group title
    From Study 2301
    Reporting group description
    		 -

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

    Reporting group title
    From Study 2211 Overall
    Reporting group description
    		 -

    Reporting group values
    		 From Study 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall Total
    Number of subjects
    		 164 397 54 162 723
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 152 376 54 160 688
        From 65-84 years
    		 12 21 0 2 35
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.5 ( 9.89 ) 46.4 ( 11.7 ) 40.9 ( 10.98 ) 43.7 ( 10.89 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 182 15 61 301
        Male
    		 106 215 39 101 422

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    From Study 2210
    Reporting group description
    		 -

    Reporting group title
    From Study 2301
    Reporting group description
    		 -

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

    Reporting group title
    From Study 2211 Overall
    Reporting group description
    		 -

    Primary: Percentage of patients maintaining HCV RNA load below LOQ (Full Analysis Set)

    		 Close Top of page
    End point title
    		 Percentage of patients maintaining HCV RNA load below LOQ (Full Analysis Set) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline through Week 48
    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 statistical analyses have been performed for this primary end point.
    End point values
    		 From Study 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall
    Number of subjects analysed
    161 [2]
    383 [3]
    53 [4]
    160 [5]
    Units: percent
    number (not applicable)
        Week 1
    96.7
    99.5
    100
    100
        Week 24
    100
    100
    98
    99.3
        Week 48
    100
    99.7
    100
    100
    Notes
    [2] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [3] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [4] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [5] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    No statistical analyses for this end point

    Secondary: Percentage of patients with normal Alanine-aminotransferase (ALT)

    		 Close Top of page
    End point title
    		 Percentage of patients with normal Alanine-aminotransferase (ALT)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 From Study 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall
    Number of subjects analysed
    161 [6]
    383 [7]
    53 [8]
    160 [9]
    Units: percent
    number (not applicable)
        Week 1
    88.8
    94
    96
    95.5
        Week 24
    84
    93.9
    82
    89.4
        Week 48
    88.2
    91.5
    87.2
    91.5
    Notes
    [6] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [7] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [8] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    [9] - Full Analysis Set- all patients who enrolled into this study and had at least one HCV RNA assessment
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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 reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    From Study 2210
    Reporting group description
    		 From Study 2210

    Reporting group title
    From Study 2301
    Reporting group description
    		 From Study 2301

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

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

    Serious adverse events
    		 From Study 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 164 (4.27%)
    8 / 397 (2.02%)
    1 / 54 (1.85%)
    3 / 162 (1.85%)
         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)
    BLADDER CANCER
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BREAST CANCER IN SITU
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    1 / 162 (0.62%)
         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
    CHOLESTEATOMA
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATIC CANCER
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATOCELLULAR CARCINOMA
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ABDOMINAL WOUND DEHISCENCE
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CONCUSSION
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    1 / 162 (0.62%)
         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
    CONTUSION
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    1 / 162 (0.62%)
         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
    FIBULA FRACTURE
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    HYPOCHROMIC ANAEMIA
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    ALCOHOL ABUSE
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    0 / 164 (0.00%)
    0 / 397 (0.00%)
    1 / 54 (1.85%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    COLLAGEN DISORDER
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    HERPES SIMPLEX MENINGITIS
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MENINGITIS VIRAL
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OSTEOMYELITIS ACUTE
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OTITIS MEDIA CHRONIC
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMOCOCCAL SEPSIS
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 164 (0.00%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         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 2210 From Study 2301 From Study 2211 IFN-free From Study 2211 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 164 (8.54%)
    12 / 397 (3.02%)
    5 / 54 (9.26%)
    11 / 162 (6.79%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 164 (2.44%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Gastrointestinal disorders
    FLATULENCE
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    2 / 54 (3.70%)
    2 / 162 (1.23%)
         occurrences all number
    1
    0
    2
    2
    Hepatobiliary disorders
    HEPATIC STEATOSIS
         subjects affected / exposed
    4 / 164 (2.44%)
    7 / 397 (1.76%)
    1 / 54 (1.85%)
    3 / 162 (1.85%)
         occurrences all number
    4
    7
    1
    3
    HEPATOMEGALY
         subjects affected / exposed
    4 / 164 (2.44%)
    1 / 397 (0.25%)
    0 / 54 (0.00%)
    0 / 162 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    1 / 164 (0.61%)
    0 / 397 (0.00%)
    2 / 54 (3.70%)
    5 / 162 (3.09%)
         occurrences all number
    1
    0
    2
    5
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    4 / 164 (2.44%)
    4 / 397 (1.01%)
    1 / 54 (1.85%)
    3 / 162 (1.85%)
         occurrences all number
    4
    4
    1
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2013
    This study was initially designed to follow-up patients from various Novartis feeder studies for 2 years which was later shortened to 48 weeks.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 May 2015
    After a comprehensive portfolio review, and in ight of the advancement of several successful oral anti-HCV agents, Novartis decided to no longer focus on HCV development. The compound DEB025 has been returned to the company from which it was licensed. This decision was not in any way affected or influenced by new safety data for DEB025.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

    European Medicines Agency © 1995-Fri Apr 26 09:33:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA