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    Clinical Trial Results:
    A multicenter, open-label, randomized, 2-arm, phase II trial of pharmacodynamics, pharmacokinetics and safety of two dose regimens of DEB025/alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 patients who have previously failed interferon therapy or are intolerant or unable to take interferon.

    Summary
    EudraCT number
    		 2013-003751-38
    Trial protocol
    		 FR  
    Global end of trial date
    21 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CDEB025A2233
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02094443
    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
    21 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate pharmacodynamics, pharmacokinetic between 2 treatment groups receiving different doses of DEB025 in combination with RBV
    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
    20 Mar 2014
    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
    France: 25
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    52
    EEA total number of subjects
    25
    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)
    49
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Informed consent was obtained from each patient in writing at screening visit 1. The study was described to the patient by a study nurse, the investigator or a study coordinator, who answered any questions, and written information was also provided.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DEB300 + RBV
    Arm description
    		 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2 , and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the responses at Week 2, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025300
    Investigational medicinal product code
    Other name
    Alisporivir
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    DEB025 (300 mg BID): 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg/day or 1200 mg/day orally (depending on weight)

    Arm title
    		 DEB400 + RBV
    Arm description
    		 DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2, and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the response at Week 2, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg/day or 1200 mg/day orally (depending on weight)

    Investigational medicinal product name
    DEB025400
    Investigational medicinal product code
    Other name
    Alisporivir
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2

    Number of subjects in period 1
    		DEB300 + RBV DEB400 + RBV
    Started
    26
    26
    Completed
    11
    9
    Not completed
    15
    17
         Physician decision
    1
    -
         Adverse event, non-fatal
    3
    6
         Patient/guardian decision
    1
    2
         Lack of efficacy
    10
    8
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Post-treatment follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 DEB300 + RBV
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025300
    Investigational medicinal product code
    Other name
    Alisporivir
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    DEB025 (300 mg BID): 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg/day or 1200 mg/day orally (depending on weight)

    Arm title
    		 DEB400 + RBV
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025400
    Investigational medicinal product code
    Other name
    Alisporivir
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg/day or 1200 mg/day orally (depending on weight)

    Number of subjects in period 2
    		DEB300 + RBV DEB400 + RBV
    Started
    23
    23
    Completed
    11
    13
    Not completed
    12
    10
         Study terminated by sponsor
    9
    7
         Patient/guardian decision
    2
    1
         Lost to follow-up
    1
    1
         New therapy for study indication
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DEB300 + RBV
    Reporting group description
    		 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2 , and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the responses at Week 2, respectively.

    Reporting group title
    DEB400 + RBV
    Reporting group description
    		 DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2, and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the response at Week 2, respectively.

    Reporting group values
    		 DEB300 + RBV DEB400 + RBV Total
    Number of subjects
    		 26 26 52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 25 24 49
        From 65-84 years
    		 1 2 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.4 ± 8.25 54.5 ± 7.62 -
    Gender categorical
    Units: Subjects
        Female
    		 8 12 20
        Male
    		 18 14 32

    End points

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    End points reporting groups
    Reporting group title
    DEB300 + RBV
    Reporting group description
    		 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2 , and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the responses at Week 2, respectively.

    Reporting group title
    DEB400 + RBV
    Reporting group description
    		 DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2, and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the response at Week 2, respectively.
    Reporting group title
    DEB300 + RBV
    Reporting group description
    		 -

    Reporting group title
    DEB400 + RBV
    Reporting group description
    		 -

    Primary: Viral load drop from baseline through Week 12

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    End point title
    		 Viral load drop from baseline through Week 12 [1]
    End point description
    Defined as the change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline through Week 12. Baseline is defined as the last non-missing value before first administration of study drug. At each time point, only patients with a value at both Baseline and that time point are included.
    End point type
    Primary
    End point timeframe
    Baseline through 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 statistical analyses have been performed for this primary end point.
    End point values
    		 DEB300 + RBV DEB400 + RBV
    Number of subjects analysed
    26 [2]
    26 [3]
    Units: IU/mL
    arithmetic mean (standard deviation)
        Baseline
    6.323 ± 6.323
    6.343 ± 0.6396
        Change at Day 3
    -0.316 ± 0.5494
    -0.692 ± 0.8812
        Change at Week 1
    -0.785 ± 0.7705
    -1.564 ± 0.9481
        Change at Day 10
    -1.058 ± 0.9963
    -1.803 ± 1.1674
        Change at Week 2
    -1.507 ± 0.9645
    -2.606 ± 1.2005
        Change at Week 3
    -1.863 ± 1.2377
    -3.474 ± 1.3669
        Change at Week 4
    -2.596 ± 1.3034
    -3.84 ± 1.4611
        Change at Week 6
    -3.058 ± 1.7385
    -4.232 ± 1.5875
        Change at Week 8
    -3.438 ± 2.1797
    -3.98 ± 2.219
        Change at Week 12
    -3.935 ± 2.3361
    -3.855 ± 2.7506
    Notes
    [2] - N= 26, 14, 24, 17, 23, 18, 23, 23, 23, 21
    [3] - N= 26, 17 24, 12, 24, 17, 24, 21, 22, 18
    No statistical analyses for this end point

    Secondary: Number (%) of patients who Sustained Virologic Response (SVR) 12

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    End point title
    		 Number (%) of patients who Sustained Virologic Response (SVR) 12
    End point description
    Number of participants who maintain undetectable Heptatis C virus 12 weeks after end of treatment between 2 treatment arms.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 DEB300 + RBV DEB400 + RBV
    Number of subjects analysed
    26
    26
    Units: percent
        number (confidence interval 95%)
    19.2 (6.6 to 39.4)
    26.9 (11.6 to 47.8)
    No statistical analyses for this end point

    Secondary: Confirmed viral breakthrough, relapse, or normalized ALT

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    End point title
    		 Confirmed viral breakthrough, relapse, or normalized ALT
    End point description
    Confirmed viral breakthrough is defined as two consecutive episodes of: increase of HCV RNA by ≥ 1 log10 above nadir (where nadir is the lowest HCV RNA level during treatment) and HCV RNA ≥ 100 IU / mL (2 log10) while still on treatment), or HCV RNA ≥ 100 IU / mL (2 log10) after previously being undetectable while still on treatment. Relapse is defined as patients with non-missing and positive follow-up HCV RNA results after imputation are considered as relapsers, if they fully completed assigned treatments and were ETR responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 DEB300 + RBV DEB400 + RBV
    Number of subjects analysed
    26 [4]
    26 [5]
    Units: percent
    number (not applicable)
        Confirmed viral breakthrough
    23.1
    34.6
        Confirmed viral breakthrough during treatment
    23.1
    34.6
        Relapse
    19.2
    19.2
        ALT abnormal at baseline/normalized treatment end
    73.1
    61.5
        ALT abnormal at baseline/normalized at study end
    38.5
    42.3
    Notes
    [4] - N= 6, 6, 5, 19, 10
    [5] - N = 9, 9, 5, 16, 11
    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 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
    DEB400+RBV
    Reporting group description
    		 DEB025 (400 mg BID): 2 capsules (200 mg) BID for 12 or 24 weeks depending on the response at Week 2, and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the response at Week 2, respectively.

    Reporting group title
    DEB300+RBV
    Reporting group description
    		 1 capsule of 200 mg and 1 capsule of 100 mg or 3 capsules (100 mg) BID for 12 or 24 weeks depending on the response at Week 2 , and Ribavirin: 1000 mg/day or 1200 mg/day orally (depending on weight) in two divided doses for 12 or 24 weeks depending on the responses at Week 2, respectively.

    Serious adverse events
    		 DEB400+RBV DEB300+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    EPIGLOTTITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DEB400+RBV DEB300+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 26 (92.31%)
    22 / 26 (84.62%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    5 / 26 (19.23%)
    4 / 26 (15.38%)
         occurrences all number
    5
    5
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    12 / 26 (46.15%)
    5 / 26 (19.23%)
         occurrences all number
    13
    5
    FATIGUE
         subjects affected / exposed
    6 / 26 (23.08%)
    6 / 26 (23.08%)
         occurrences all number
    6
    6
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    6 / 26 (23.08%)
    5 / 26 (19.23%)
         occurrences all number
    7
    5
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    DEPRESSION
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    INSOMNIA
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    IRRITABILITY
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 26 (11.54%)
         occurrences all number
    2
    3
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    HEADACHE
         subjects affected / exposed
    7 / 26 (26.92%)
    4 / 26 (15.38%)
         occurrences all number
    7
    5
    SYNCOPE
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    7 / 26 (26.92%)
    5 / 26 (19.23%)
         occurrences all number
    7
    5
    Eye disorders
    DRY EYE
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    OCULAR ICTERUS
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    CONSTIPATION
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 26 (11.54%)
         occurrences all number
    1
    3
    DIARRHOEA
         subjects affected / exposed
    4 / 26 (15.38%)
    2 / 26 (7.69%)
         occurrences all number
    4
    3
    DRY MOUTH
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    NAUSEA
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
         occurrences all number
    4
    5
    VOMITING
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 26 (7.69%)
         occurrences all number
    3
    3
    Skin and subcutaneous tissue disorders
    DRY SKIN
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    PRURITUS
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 26 (19.23%)
         occurrences all number
    4
    5
    PRURITUS GENERALISED
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    RASH
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Renal and urinary disorders
    DYSURIA
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    MUSCLE SPASMS
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 26 (7.69%)
         occurrences all number
    3
    2
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 26 (11.54%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2

    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
    16 Feb 2015
    Novartis decided to no longer focus on development of compounds for treating Hepatitis-C Virus (HCV). The compound DEB025 had 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.

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