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   43874   clinical trials with a EudraCT protocol, of which   7293   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:
    High-dose intravenous silibinin infusions during 10 days as add-on treatment to triple therapy (telaprevir, peginterferon alpha and ribavirin) in cirrhotic GT 1 hepatitis C virus infected patients being null responders to prior dual therapy with peginterferon alpha and ribavirin – a proof-of-concept trial on antiviral efficacy and safety

    Summary
    EudraCT number
    		 2012-004442-15
    Trial protocol
    		 DE  
    Global end of trial date
    03 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2020
    First version publication date
    30 Aug 2020
    Other versions
    Summary report(s)
    		 HISTORY

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HISTORY
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00005455
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany,
    Public contact
    Prof. Dr. Thomas Berg, Universität Leipzig, 49 3419712330, thomas.berg@medizin.uni-leipzig.de
    Scientific contact
    Prof. Dr. Thomas Berg, Universität Leipzig, 49 3419712330, thomas.berg@medizin.uni-leipzig.de
    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
    03 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the rates of RVR – rapid virological response, defined as HCV RNA ≤ LOQ (limit of quantification), defined as ≤ 15 IU/mL at week four of an antiviral treatment with telaprevir, peginterferon alpha and ribavirin – between patients who either receive infusions of silibinin during the first ten consecutive working days of antiviral treatment or no infusions.
    Protection of trial subjects
    see descriptions in Patient informed consent and the Trial protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2013
    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
    Germany: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 2 patients before premature trial termination

    Pre-assignment
    Screening details
    		 A total of 3 patients were to be included in the screening process of whom only one was eligible for randomisation and was randomised in the control arm.

    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
    		 control
    Arm description
    		 Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline Visite Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline Visite
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline visite

    Investigational medicinal product name
    Peginterferon alpha 2a
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline visite

    Arm title
    		 experimental
    Arm description
    		 Silibinin infusions (20 mg/kg bw/d) on 10 consecutive working days (ideally Monday to Friday sparing the weekend) +Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite + Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline visite + Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline Visite
    Arm type
    		 Experimental

    Investigational medicinal product name
    Silibinin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Silibinin infusions (20 mg/kg bw/d) on 10 consecutive working days (ideally Monday to Friday sparing the weekend)

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline visite

    Investigational medicinal product name
    Peginterferon alpha 2a
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline visite

    Number of subjects in period 1
    		control experimental
    Started
    1
    1
    Completed
    0
    0
    Not completed
    1
    1
         Physician decision
    1
    -
         screening failure
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 not reported

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 2 2
    Age categorical
    age categories used in Trial information section
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Not recorded
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0
        not recorded
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    control
    Reporting group description
    		 Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline Visite Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline Visite

    Reporting group title
    experimental
    Reporting group description
    		 Silibinin infusions (20 mg/kg bw/d) on 10 consecutive working days (ideally Monday to Friday sparing the weekend) +Telaprevir 1125 mg BID for a period of 12 weeks starting at baseline visite + Ribavirin 1000 or 1200 mg (depending on the body weight) divided in two daily doses for a period of 48 weeks starting at baseline visite + Peginterferon alpha 2a 180 µg s.c. qweek for a period of 48 weeks starting at baseline Visite

    Primary: To compare the rates of RVR – rapid virological response, defined as HCV RNA ≤ LOQ (limit of quantification), defined as ≤ 15 IU/mL at week four of an antiviral treatment with telaprevir, peginterferon alpha and ribavirin – between patients who either rec

    		 Close Top of page
    End point title
    		 To compare the rates of RVR – rapid virological response, defined as HCV RNA ≤ LOQ (limit of quantification), defined as ≤ 15 IU/mL at week four of an antiviral treatment with telaprevir, peginterferon alpha and ribavirin – between patients who either rec [1]
    End point description
    End point type
    Primary
    End point timeframe
    4 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: The trial was stopped prematurely and only a very limited number of patients included, which does not allow an endpoint analysis. For further descriptions please see the attached trial synopsis.
    End point values
    		 control experimental
    Number of subjects analysed
    1
    1
    Units: whole
    1
    1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events will be documented at every visit from the baseline visit (visit 2) until visit 18/week FU 12 = End of Event Reporting = EoER)
    Adverse event reporting additional description
    Not recorded
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see the list of AEs related and not related to the IMP in the trial synopsis, uploaded together with the posting of this results report.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2013
    Change of co-ordinating investigator Change of a principal Investigator at a trial site

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Mar 2014
    The study was aborted prematurely due to current developments in the field of treatment of chronic hepatitis C patients (i.e. approval of new antiviral agents).
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was aborted prematurely due to current developments in the field of treatment of chronic hepatitis C patients (i.e. approval of new antiviral agents).
    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-Wed May 08 22:53:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA