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   43875   clinical trials with a EudraCT protocol, of which   7295   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 multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNα2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patients

    Summary
    EudraCT number
    		 2010-020034-26
    Trial protocol
    		 DE   PL   GB   BE   IT  
    Global end of trial date
    15 May 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2016
    First version publication date
    18 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CDEB025A2211
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01215643
    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
    15 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients.
    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
    21 Oct 2010
    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: 33
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 24
    Country: Number of subjects enrolled
    United States: 40
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    India: 60
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Taiwan: 29
    Country: Number of subjects enrolled
    Thailand: 44
    Worldwide total number of subjects
    340
    EEA total number of subjects
    121
    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)
    337
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Approximately 400 patients were planned to be randomized in a 2:2:2:1:1 ratio. Due to higher screen failure rate and difficulties in enrollment, the targeted sample size was not reached within the targeted time frame. The recruitment was stopped after 340 patients were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DEB025 1000 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg soft gel capsules taken orally.

    Arm title
    		 DEB025 600 mg + RBV
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg soft gel capsules taken orally.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Ribavirin
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets or capsules taken orally.

    Arm title
    		 DEB025 800 mg +RBV
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg soft gel capsules taken orally.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Ribavirin
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets or capsules taken orally.

    Arm title
    		 DEB025 600 mg +PEG
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEB025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg soft gel capsules taken orally.

    Investigational medicinal product name
    PEG
    Investigational medicinal product code
    Other name
    Peg-IFN alfa-2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Syringes containing 180 µg/0.5 mL Peg-IFNα2a for s.c. injection.

    Arm title
    		 PEG + RBV
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PEG
    Investigational medicinal product code
    Other name
    Peg-IFN alfa-2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Syringes containing 180 µg/0.5 mL Peg-IFNα2a for s.c. injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Ribavirin
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets or capsules taken orally.

    Number of subjects in period 1
    		DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV
    Started
    83
    84
    94
    39
    40
    Treated
    82
    84
    94
    39
    37
    Completed
    73
    78
    85
    35
    33
    Not completed
    10
    6
    9
    4
    7
         Abnormal laboratory value(s)
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    2
    -
    1
    -
    3
         Adverse event, non-fatal
    2
    2
    3
    3
    -
         Unsatisfactory therapeutic effect
    2
    2
    2
    1
    -
         Non-compliance
    1
    2
    -
    -
    -
         Lost to follow-up
    -
    -
    3
    -
    3
         Protocol deviation
    2
    -
    -
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DEB025 1000 mg
    Reporting group description
    		 -

    Reporting group title
    DEB025 600 mg + RBV
    Reporting group description
    		 -

    Reporting group title
    DEB025 800 mg +RBV
    Reporting group description
    		 -

    Reporting group title
    DEB025 600 mg +PEG
    Reporting group description
    		 -

    Reporting group title
    PEG + RBV
    Reporting group description
    		 -

    Reporting group values
    		 DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV Total
    Number of subjects
    		 83 84 94 39 40 340
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 83 82 94 38 40 337
        From 65-84 years
    		 0 2 0 1 0 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.2 ( 11.27 ) 42.8 ( 11.77 ) 42.6 ( 11 ) 43.2 ( 10.56 ) 39.9 ( 11.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 28 33 14 16 123
        Male
    		 51 56 61 25 24 217

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DEB025 1000 mg
    Reporting group description
    		 -

    Reporting group title
    DEB025 600 mg + RBV
    Reporting group description
    		 -

    Reporting group title
    DEB025 800 mg +RBV
    Reporting group description
    		 -

    Reporting group title
    DEB025 600 mg +PEG
    Reporting group description
    		 -

    Reporting group title
    PEG + RBV
    Reporting group description
    		 -

    Primary: Percentage of patients who achieve Rapid Viral Response (RVR)

    		 Close Top of page
    End point title
    		 Percentage of patients who achieve Rapid Viral Response (RVR) [1]
    End point description
    Defined as serum Hepatitis C Virus (HCV) RNA undetectable (by Limit of quantification (LOQ)) after 4 weeks of treatment.
    End point type
    Primary
    End point timeframe
    week 4
    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
    		 DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV
    Number of subjects analysed
    81 [2]
    84 [3]
    93 [4]
    39 [5]
    40 [6]
    Units: percent
        number (not applicable)
    28.4
    36.9
    41.9
    84.6
    72.5
    Notes
    [2] - Full Analysis Set (FAS) - all subjects to whom study treatment had been assigned
    [3] - Full Analysis Set (FAS)
    [4] - Full Analysis Set (FAS)
    [5] - Full Analysis Set (FAS)
    [6] - Full Analysis Set (FAS)
    No statistical analyses for this end point

    Secondary: Percentage of patients with RVR on interferon free treatment who achieve Sustained Viral Response (SVR24) at Week 24

    		 Close Top of page
    End point title
    		 Percentage of patients with RVR on interferon free treatment who achieve Sustained Viral Response (SVR24) at Week 24
    End point description
    defined as serum HCV RNA undetectable (by LOD) after 24 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV
    Number of subjects analysed
    81 [7]
    84 [8]
    93 [9]
    39 [10]
    40 [11]
    Units: percent
        number (not applicable)
    80.2
    84.5
    80.6
    79.5
    57.5
    Notes
    [7] - Full Analysis Set (FAS) - all subjects to whom study treatment had been assigned
    [8] - Full Analysis Set (FAS)
    [9] - Full Analysis Set (FAS)
    [10] - Full Analysis Set (FAS)
    [11] - Full Analysis Set (FAS)
    No statistical analyses for this end point

    Secondary: Percentage of participants with cEVR, ETR (week 24), SVR12 and SVR24 measured at the level of quantification (LOQ)

    		 Close Top of page
    End point title
    		 Percentage of participants with cEVR, ETR (week 24), SVR12 and SVR24 measured at the level of quantification (LOQ)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12 and 24
    End point values
    		 DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV
    Number of subjects analysed
    81 [12]
    84 [13]
    93 [14]
    39 [15]
    40 [16]
    Units: percent
    number (not applicable)
        RVR4LOQ (=RVR)
    28.4
    36.9
    41.9
    84.6
    72.5
        EVR12LOQ (=EVR)
    93.8
    95.2
    91.4
    97.4
    85
        pEVR
    0
    0
    1.1
    2.6
    0
        cEVR12LOQ
    93.8
    95.2
    90.3
    94.9
    85
        ETR24LOQ
    95.1
    96.4
    95.7
    94.9
    87.5
        SVR12LOQ
    81.5
    84.5
    80.6
    76.9
    62.5
        SVR24LOQ
    80.2
    84.5
    80.6
    79.5
    57.5
    Notes
    [12] - Full Analysis Set (FAS): all participants that study treatment had been assigned.
    [13] - FAS
    [14] - FAS
    [15] - FAS
    [16] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of participants with SVR12LOQ and SVR24LOQ by actual genotype and screening HCV RNA

    		 Close Top of page
    End point title
    		 Percentage of participants with SVR12LOQ and SVR24LOQ by actual genotype and screening HCV RNA
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12 and 24
    End point values
    		 DEB025 1000 mg DEB025 600 mg + RBV DEB025 800 mg +RBV DEB025 600 mg +PEG PEG + RBV
    Number of subjects analysed
    81 [17]
    84 [18]
    93 [19]
    39 [20]
    40 [21]
    Units: percent
    number (not applicable)
        SVR12LOQ - Genotype 2
    78.3
    76.7
    76.9
    72.7
    61.5
        SVR12LOQ - Genotype 3
    82.8
    88.9
    82.1
    78.6
    63
        SVR12LOQ - Screening HCV RNA ≥ 800,000 IU/mL
    88
    85.5
    81.8
    73.1
    66.7
        SVR12LOQ - Screening HCV RNA < 800,000 IU/mL
    73.3
    82.8
    78.9
    84.6
    53.8
        SVR24LOQ - Genotype 2
    78.3
    76.7
    76.9
    72.7
    53.8
        SVR24LOQ - Genotype 3
    81
    88.9
    82.1
    82.1
    59.3
        SVR24LOQ - Screening HCV RNA ≥ 800,000 IU/mL
    88
    85.5
    81.8
    73.1
    59.3
        SVR24LOQ - Screening HCV RNA < 800,000 IU/mL
    70
    82.8
    78.9
    92.3
    53.8
    Notes
    [17] - FAS: n/N = 18/23; 48/58; 44/50; 22/30
    [18] - FAS: n/N = 23/30; 48/54; 47/55; 24/29
    [19] - FAS: n/N = 8/11; 22/28; 19/26; 11/13
    [20] - FAS: n/N = 18/13; 17/27; 18/27; 7/13
    [21] - FAS: n/N = 8/13; 17/27; 18/27; 7/13
    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
    15.0
    Reporting groups
    Reporting group title
    DEB025 1000 mg
    Reporting group description
    		 DEB025 1000 mg

    Reporting group title
    DEB025 600mg+RBV
    Reporting group description
    		 DEB025 600mg+RBV

    Reporting group title
    DEB025 800mg+RBV
    Reporting group description
    		 DEB025 800mg+RBV

    Reporting group title
    DEB025 600mg+PEG
    Reporting group description
    		 DEB025 600mg+PEG

    Reporting group title
    PEG+RBV
    Reporting group description
    		 PEG+RBV

    Serious adverse events
    		 DEB025 1000 mg DEB025 600mg+RBV DEB025 800mg+RBV DEB025 600mg+PEG PEG+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 82 (4.88%)
    1 / 84 (1.19%)
    9 / 94 (9.57%)
    4 / 39 (10.26%)
    2 / 37 (5.41%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Maternal exposure during pregnancy
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinopathy
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Homicidal ideation
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 84 (1.19%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DEB025 1000 mg DEB025 600mg+RBV DEB025 800mg+RBV DEB025 600mg+PEG PEG+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 82 (78.05%)
    69 / 84 (82.14%)
    76 / 94 (80.85%)
    37 / 39 (94.87%)
    30 / 37 (81.08%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 82 (10.98%)
    10 / 84 (11.90%)
    8 / 94 (8.51%)
    5 / 39 (12.82%)
    1 / 37 (2.70%)
         occurrences all number
    9
    11
    8
    5
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 82 (12.20%)
    7 / 84 (8.33%)
    11 / 94 (11.70%)
    3 / 39 (7.69%)
    8 / 37 (21.62%)
         occurrences all number
    10
    7
    12
    3
    9
    Chills
         subjects affected / exposed
    5 / 82 (6.10%)
    3 / 84 (3.57%)
    5 / 94 (5.32%)
    4 / 39 (10.26%)
    1 / 37 (2.70%)
         occurrences all number
    5
    3
    5
    4
    1
    Fatigue
         subjects affected / exposed
    21 / 82 (25.61%)
    23 / 84 (27.38%)
    30 / 94 (31.91%)
    18 / 39 (46.15%)
    10 / 37 (27.03%)
         occurrences all number
    22
    24
    33
    20
    10
    Feeling cold
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    2 / 94 (2.13%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    0
    2
    Influenza like illness
         subjects affected / exposed
    8 / 82 (9.76%)
    6 / 84 (7.14%)
    9 / 94 (9.57%)
    8 / 39 (20.51%)
    4 / 37 (10.81%)
         occurrences all number
    9
    6
    9
    9
    4
    Injection site erythema
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    0
    0
    2
    2
    Irritability
         subjects affected / exposed
    2 / 82 (2.44%)
    5 / 84 (5.95%)
    8 / 94 (8.51%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    5
    8
    2
    2
    Malaise
         subjects affected / exposed
    2 / 82 (2.44%)
    3 / 84 (3.57%)
    0 / 94 (0.00%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    3
    0
    3
    2
    Pain
         subjects affected / exposed
    3 / 82 (3.66%)
    3 / 84 (3.57%)
    5 / 94 (5.32%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    3
    3
    5
    2
    1
    Pyrexia
         subjects affected / exposed
    14 / 82 (17.07%)
    16 / 84 (19.05%)
    15 / 94 (15.96%)
    12 / 39 (30.77%)
    9 / 37 (24.32%)
         occurrences all number
    17
    20
    18
    16
    13
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    2 / 94 (2.13%)
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 82 (13.41%)
    13 / 84 (15.48%)
    12 / 94 (12.77%)
    3 / 39 (7.69%)
    4 / 37 (10.81%)
         occurrences all number
    12
    13
    12
    3
    4
    Dyspnoea
         subjects affected / exposed
    3 / 82 (3.66%)
    6 / 84 (7.14%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    3
    6
    4
    2
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 82 (1.22%)
    6 / 84 (7.14%)
    4 / 94 (4.26%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    1
    6
    4
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    5 / 82 (6.10%)
    2 / 84 (2.38%)
    5 / 94 (5.32%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    5
    2
    6
    2
    1
    Productive cough
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 84 (1.19%)
    1 / 94 (1.06%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    1
    2
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    8 / 82 (9.76%)
    9 / 84 (10.71%)
    5 / 94 (5.32%)
    1 / 39 (2.56%)
    5 / 37 (13.51%)
         occurrences all number
    8
    10
    5
    1
    6
    Depressed mood
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 84 (2.38%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    2
    2
    3
    2
    0
    Depression
         subjects affected / exposed
    12 / 82 (14.63%)
    7 / 84 (8.33%)
    9 / 94 (9.57%)
    3 / 39 (7.69%)
    3 / 37 (8.11%)
         occurrences all number
    12
    7
    9
    4
    3
    Insomnia
         subjects affected / exposed
    11 / 82 (13.41%)
    12 / 84 (14.29%)
    14 / 94 (14.89%)
    4 / 39 (10.26%)
    6 / 37 (16.22%)
         occurrences all number
    11
    12
    15
    4
    8
    Sleep disorder
         subjects affected / exposed
    2 / 82 (2.44%)
    4 / 84 (4.76%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    2
    4
    3
    3
    1
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 84 (1.19%)
    1 / 94 (1.06%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    1
    1
    1
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    1 / 94 (1.06%)
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    1
    2
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 82 (1.22%)
    3 / 84 (3.57%)
    2 / 94 (2.13%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    1
    3
    2
    2
    1
    Weight decreased
         subjects affected / exposed
    4 / 82 (4.88%)
    2 / 84 (2.38%)
    4 / 94 (4.26%)
    3 / 39 (7.69%)
    4 / 37 (10.81%)
         occurrences all number
    4
    2
    4
    3
    4
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 84 (2.38%)
    6 / 94 (6.38%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    7
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 82 (2.44%)
    2 / 84 (2.38%)
    4 / 94 (4.26%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    3
    5
    2
    2
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    3 / 82 (3.66%)
    1 / 84 (1.19%)
    4 / 94 (4.26%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    4
    2
    1
    Dizziness
         subjects affected / exposed
    6 / 82 (7.32%)
    11 / 84 (13.10%)
    16 / 94 (17.02%)
    5 / 39 (12.82%)
    4 / 37 (10.81%)
         occurrences all number
    6
    13
    16
    5
    4
    Dysgeusia
         subjects affected / exposed
    4 / 82 (4.88%)
    3 / 84 (3.57%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    4
    3
    4
    2
    0
    Headache
         subjects affected / exposed
    19 / 82 (23.17%)
    18 / 84 (21.43%)
    27 / 94 (28.72%)
    16 / 39 (41.03%)
    7 / 37 (18.92%)
         occurrences all number
    21
    30
    30
    20
    16
    Hypoaesthesia
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 84 (2.38%)
    1 / 94 (1.06%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    Memory impairment
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 84 (1.19%)
    2 / 94 (2.13%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    2
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 84 (1.19%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    1
    4
    3
    2
    1
    Somnolence
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 84 (1.19%)
    1 / 94 (1.06%)
    4 / 39 (10.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    1
    4
    3
    Syncope
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 82 (9.76%)
    11 / 84 (13.10%)
    10 / 94 (10.64%)
    4 / 39 (10.26%)
    3 / 37 (8.11%)
         occurrences all number
    8
    12
    10
    4
    4
    Leukopenia
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 84 (2.38%)
    2 / 94 (2.13%)
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    3
    3
    2
    2
    4
    Neutropenia
         subjects affected / exposed
    9 / 82 (10.98%)
    8 / 84 (9.52%)
    13 / 94 (13.83%)
    10 / 39 (25.64%)
    4 / 37 (10.81%)
         occurrences all number
    10
    10
    16
    15
    5
    Thrombocytopenia
         subjects affected / exposed
    0 / 82 (0.00%)
    5 / 84 (5.95%)
    3 / 94 (3.19%)
    6 / 39 (15.38%)
    2 / 37 (5.41%)
         occurrences all number
    0
    5
    3
    6
    4
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    2
    Vertigo
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 84 (1.19%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    1
    1
    1
    0
    4
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 84 (0.00%)
    0 / 94 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 82 (3.66%)
    5 / 84 (5.95%)
    6 / 94 (6.38%)
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    3
    6
    7
    3
    0
    Abdominal pain
         subjects affected / exposed
    6 / 82 (7.32%)
    4 / 84 (4.76%)
    7 / 94 (7.45%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    9
    4
    7
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    6 / 82 (7.32%)
    6 / 84 (7.14%)
    7 / 94 (7.45%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    6
    7
    9
    2
    1
    Constipation
         subjects affected / exposed
    5 / 82 (6.10%)
    5 / 84 (5.95%)
    8 / 94 (8.51%)
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    5
    5
    9
    3
    0
    Diarrhoea
         subjects affected / exposed
    13 / 82 (15.85%)
    6 / 84 (7.14%)
    10 / 94 (10.64%)
    9 / 39 (23.08%)
    1 / 37 (2.70%)
         occurrences all number
    17
    7
    12
    11
    2
    Dry mouth
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 84 (2.38%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    3
    2
    3
    3
    1
    Dyspepsia
         subjects affected / exposed
    7 / 82 (8.54%)
    8 / 84 (9.52%)
    7 / 94 (7.45%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    8
    10
    7
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 84 (2.38%)
    0 / 94 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    Mouth ulceration
         subjects affected / exposed
    5 / 82 (6.10%)
    0 / 84 (0.00%)
    3 / 94 (3.19%)
    4 / 39 (10.26%)
    2 / 37 (5.41%)
         occurrences all number
    6
    0
    4
    5
    2
    Nausea
         subjects affected / exposed
    17 / 82 (20.73%)
    15 / 84 (17.86%)
    23 / 94 (24.47%)
    9 / 39 (23.08%)
    5 / 37 (13.51%)
         occurrences all number
    19
    16
    26
    9
    5
    Vomiting
         subjects affected / exposed
    7 / 82 (8.54%)
    7 / 84 (8.33%)
    7 / 94 (7.45%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    8
    8
    13
    4
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 82 (3.66%)
    2 / 84 (2.38%)
    5 / 94 (5.32%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    3
    2
    6
    0
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 82 (12.20%)
    8 / 84 (9.52%)
    4 / 94 (4.26%)
    9 / 39 (23.08%)
    7 / 37 (18.92%)
         occurrences all number
    10
    8
    4
    9
    7
    Dry skin
         subjects affected / exposed
    8 / 82 (9.76%)
    5 / 84 (5.95%)
    6 / 94 (6.38%)
    3 / 39 (7.69%)
    3 / 37 (8.11%)
         occurrences all number
    9
    5
    7
    3
    3
    Eczema
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 84 (0.00%)
    2 / 94 (2.13%)
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    2
    0
    2
    0
    4
    Erythema
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 84 (1.19%)
    2 / 94 (2.13%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    Pruritus
         subjects affected / exposed
    14 / 82 (17.07%)
    14 / 84 (16.67%)
    12 / 94 (12.77%)
    7 / 39 (17.95%)
    6 / 37 (16.22%)
         occurrences all number
    16
    17
    15
    9
    8
    Rash
         subjects affected / exposed
    11 / 82 (13.41%)
    9 / 84 (10.71%)
    14 / 94 (14.89%)
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    14
    9
    20
    2
    5
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 82 (1.22%)
    2 / 84 (2.38%)
    1 / 94 (1.06%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    1
    2
    1
    2
    0
    Hypothyroidism
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 84 (1.19%)
    3 / 94 (3.19%)
    4 / 39 (10.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    1
    3
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 82 (10.98%)
    2 / 84 (2.38%)
    15 / 94 (15.96%)
    10 / 39 (25.64%)
    5 / 37 (13.51%)
         occurrences all number
    10
    2
    16
    11
    7
    Back pain
         subjects affected / exposed
    5 / 82 (6.10%)
    4 / 84 (4.76%)
    10 / 94 (10.64%)
    4 / 39 (10.26%)
    0 / 37 (0.00%)
         occurrences all number
    5
    4
    10
    4
    0
    Muscle spasms
         subjects affected / exposed
    4 / 82 (4.88%)
    3 / 84 (3.57%)
    3 / 94 (3.19%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    4
    3
    3
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    5 / 82 (6.10%)
    3 / 84 (3.57%)
    0 / 94 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    5
    3
    0
    0
    1
    Myalgia
         subjects affected / exposed
    10 / 82 (12.20%)
    7 / 84 (8.33%)
    13 / 94 (13.83%)
    8 / 39 (20.51%)
    8 / 37 (21.62%)
         occurrences all number
    10
    7
    15
    11
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 82 (6.10%)
    4 / 84 (4.76%)
    5 / 94 (5.32%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    6
    4
    5
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 82 (2.44%)
    3 / 84 (3.57%)
    4 / 94 (4.26%)
    4 / 39 (10.26%)
    3 / 37 (8.11%)
         occurrences all number
    2
    6
    4
    5
    3
    Urinary tract infection
         subjects affected / exposed
    5 / 82 (6.10%)
    1 / 84 (1.19%)
    1 / 94 (1.06%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    5
    1
    1
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    15 / 82 (18.29%)
    14 / 84 (16.67%)
    14 / 94 (14.89%)
    10 / 39 (25.64%)
    9 / 37 (24.32%)
         occurrences all number
    17
    14
    16
    10
    9

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2010
    The major changes that were made to the protocol with Amendment 1 were as follows: Exclusion criteria 11 and 13 were changed to make sure women of child-bearing potential use highly effective contraception i.e. total abstinence, sterilization, male partner sterilization, or a combination of two specified contraceptive methods. A rationale for birth control to be used in this study was added. Substrates of cytochrome P450 3A for which a potentially clinically important interaction was expected and not yet investigated (e.g., hormonal contraceptives, etc.) was added to the list of prohibited treatment .
    15 Dec 2010
    The major changes that were made to the protocol with Amendment 2 were as follows: • Inclusion criteria 2 were changed to allow patients up to 70 years of age to participate in the study. • Inclusion criteria 4 were changed to clarify the definition of chronic hepatitis C. • Exclusion criteria were added to exclude patients with hyperbilirubinemia or Gilbert’s disease, or use of illicit drugs. • The algorithm for DEB025 dose adjustments and interruptions in response to DEB025-induced hyperbilirubinemia was changed. DEB025 dosing was adjusted or interrupted, if no decrease in total bilirubin level was observed in a repeat bilirubin test one week later. • The list of prohibited treatment was updated. • Text was added to clarify that patients who experienced a confirmed viral breakthrough and null non-responders were discontinued from study medication but continued follow up in the study. Partial non-responders should have continued study medication and study. • Correction of the Treatment Satisfaction Questionnaire for Medication (TSQM) modified version 1.4 into TSQM version. • Editorial changes throughout the document.
    22 Dec 2010
    Canada only: • The definition of post-menopausal in exclusion criterion 13 was changed to require 12 months of spontaneous amenorrhea. • Cap and sponge were removed from the list of highly effective contraception in exclusion criterion .
    06 Jun 2011
    To adapt the requirement to discontinue study treatment for patients with a confirmed viral breakthrough if this occurs in the first 12 weeks of study treatment. Viral load variations in the first four weeks of the study should have not been construed to be viral breakthrough. If the patient's viral load was still positive at week 4 (> LOQ), then the patient should have been allowed to receive intensification to triple therapy (DEB025 600 mg QD and Peg-IFNα2a/RBV) for sufficient time to benefit from treatment, instead of being discontinued from study treatment because of a variable early response to treatment. The study design ensured that all patients received sufficient treatment before they may have been considered as treatment failures, and discontinued from the study. In addition, a correction in the documentation was needed in case male partner sterilization was implemented. Further, the interim analysis plan was adapted to include additional time points for interim analyses at 12 weeks and 24 weeks treatment as well as the final sample size was adapted.
    28 Feb 2012
    The corrections in the Viral Response Definitions table to better align the definitions with AASLD guidelines The addition of the exploratory objectives related to the pharmacokinetic of RBV (Ribavirin). Some cross-references to the Viral Response Definitions table. Limited changes to allow the measurement of RBV plasma level concentrations on the DEB025 PK samples already collected. Editorial changes throughout the document .

    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.
    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 May 17 13:44:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA