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   44339   clinical trials with a EudraCT protocol, of which   7369   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:
    An Open, Multicentre, Phase IV Study, Evaluating the Effect of a Drop In Hemoglobin Level on the Rate of Sustained Virologic Response In Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO)

    Summary
    EudraCT number
    2011-001256-10
    Trial protocol
    CZ  
    Global end of trial date
    22 Jan 2014

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    ML25186
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01585324
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    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 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this clinical study was the determination of a possible coincidence between the drop in hemoglobin concentration and the number of achieved sustained virologic response (SVR) in participants with chronic hepatitis C, infected by genotype 1, treated with ribavirin (Copegus®) in a combination with standard treatment of chronic hepatitis C (peginterferon alpha-2a).
    Protection of trial subjects
    The clinical study was performed in accordance with ICH-GCP and Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jan 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This clinical trial was originally planned in 4 clinical trial centers in the Czech Republic. However, due to a failure in manufacturing of the drug Pegasys, three of the previously approved study centers withdrew from participation. Consequently the sponsor decided to conduct the clinical trial in one of the four originally planned centers.

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

    Arms
    Arm title
    Peginterferon Alpha-2a + Ribavirin
    Arm description
    Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than [<] 75 kilogram [kg]; 1200 mg if weight greater than or equal to [≥] 75 kg) orally split into 2 daily divided doses, for a total of 48 weeks .
    Arm type
    Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) tablet orally once daily in 2 divided doses, for a total of 48 weeks.

    Investigational medicinal product name
    Peginterferon alpha-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week, for a total of 48 weeks.

    Number of subjects in period 1
    Peginterferon Alpha-2a + Ribavirin
    Started
    30
    Completed
    30

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study Period
    Reporting group description
    All participants who received at least 1 dose of study drug were included.

    Reporting group values
    Overall Study Period Total
    Number of subjects
    30 30
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.1 ( 7.2 ) -
    Gender categorical
    Units: Subjects
        Female
    1 1
        Male
    29 29

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Peginterferon Alpha-2a + Ribavirin
    Reporting group description
    Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than [<] 75 kilogram [kg]; 1200 mg if weight greater than or equal to [≥] 75 kg) orally split into 2 daily divided doses, for a total of 48 weeks .

    Subject analysis set title
    Participants With SVR
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

    Subject analysis set title
    Participants Without SVR
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

    Primary: Percentage of Participants With SVR 24 Weeks After end of Treatment

    Close Top of page
    End point title
    Percentage of Participants With SVR 24 Weeks After end of Treatment [1]
    End point description
    SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. Intention-to-treat (ITT) Population defined as all enrolled participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    24 weeks after the end of treatment (72 weeks)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to EudraCT limitation, it is not possible to provide statistical analysis for single arm.
    End point values
    Peginterferon Alpha-2a + Ribavirin
    Number of subjects analysed
    30
    Units: percentage of participants
        number (confidence interval 95%)
    83.3 (65.28 to 94.36)
    No statistical analyses for this end point

    Primary: Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR

    Close Top of page
    End point title
    Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR [2]
    End point description
    ITT Population.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [2] - 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 analysis was planned for this endpoint.
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: grams per liter (g/L)
        arithmetic mean (standard deviation)
    -23 ( 14.768 )
    -32.4 ( 11.502 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Decrease in Hemoglobin

    Close Top of page
    End point title
    Number of Participants With Decrease in Hemoglobin
    End point description
    The drop in Hb level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, >40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR. ITT Population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: Participants
        Up to 20 g/L
    9
    0
        20-40 g/L
    14
    3
        >40 g/L
    2
    2
    Statistical analysis title
    Number of Participants With Decrease in Hemoglobin
    Comparison groups
    Participants With SVR v Participants Without SVR
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0867
    Method
    Fisher exact
    Confidence interval

    Secondary: Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR

    Close Top of page
    End point title
    Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
    End point description
    The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR. ITT Population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: g/L
        arithmetic mean (standard deviation)
    124.24 ( 10.08 )
    126.6 ( 10.383 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR

    Close Top of page
    End point title
    Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
    End point description
    Number of participants with reduction in ribavirin dose due to decrease in Hb level was assessed in the group of participants who achieved SVR and in the group of participants without SVR. ITT Population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: Participants
    1
    0
    Statistical analysis title
    Participants With Reduction in Ribavirin Dose
    Comparison groups
    Participants Without SVR v Participants With SVR
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6492
    Method
    ANCOVA
    Confidence interval

    Secondary: Number of Participants With Neutropenia Among Participants With or Without SVR

    Close Top of page
    End point title
    Number of Participants With Neutropenia Among Participants With or Without SVR
    End point description
    ITT Population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Thrombocytopenia Among Participants With or Without SVR

    Close Top of page
    End point title
    Number of Participants With Thrombocytopenia Among Participants With or Without SVR
    End point description
    ITT Population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Participants With SVR Participants Without SVR
    Number of subjects analysed
    25
    5
    Units: participants
    1
    0
    Statistical analysis title
    Participants With Thrombocytopenia by SVR Status
    Comparison groups
    Participants With SVR v Participants Without SVR
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0333
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to 24 weeks after end of treatment (up to 72 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    peginterferon alpha-2a + Ribavirin
    Reporting group description
    Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight >=75 kg) orally once daily in 2 divided doses, for a total of 48 weeks.

    Serious adverse events
    peginterferon alpha-2a + Ribavirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    peginterferon alpha-2a + Ribavirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 30 (63.33%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    38
    influenza like illness
         subjects affected / exposed
    14 / 30 (46.67%)
         occurrences all number
    20

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    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 30 23:52:08 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA