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   43846   clinical trials with a EudraCT protocol, of which   7282   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:
    Hepatitis C in renal transplant recipients – Safety and efficacy of a conversion of immunosuppression to high-dose cyclosporine A and its impact on HCV-replication, parameters of liver function and glucose tolerance. An open label trial.

    Summary
    EudraCT number
    		 2011-002267-26
    Trial protocol
    		 AT  
    Global end of trial date
    01 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2022
    First version publication date
    10 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    13071981
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    Ammon Handisurya, Medizinische Universität Wien, 0043 1404004495, ammon.handisurya@meduniwien.ac.at
    Scientific contact
    Ammon Handisurya, Medizinische Universität Wien, 0043 1404004495, ammon.handisurya@meduniwien.ac.at
    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
    24 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the impact of a conversion to a cyclosporine A-based immunosuppressive regimen on HCV-replication and parameters of liver function in renal transplant recipients
    Protection of trial subjects
    frequent control visits
    Background therapy
    		 n/a
    Evidence for comparator
    		 n/a
    Actual start date of recruitment
    01 Aug 2011
    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
    Austria: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All HCV-positive RTRs who were admitted at the outpatient department of the Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, between 01-July-2011 and 31-Aug 2012, were assessed for eligibility.

    Pre-assignment
    Screening details
    		 Inclusion criteria comprised written informed consent, prior renal transplantation, current treatment with TAC, HCV infection and age 18–70 years. Subjects with known CyA-intolerance or current renal replacement therapy and pregnant or breastfeeding women were excluded.

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

    Arms
    Arm title
    		 CyA Sandimmun capsules
    Arm description
    		 to twice daily oral CyA (Sandimmun capsules, Novartis GmBH)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CyA (Sandimmun capsules, Novaritis GmbH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    twice daily

    Number of subjects in period 1
    		CyA Sandimmun capsules
    Started
    12
    Completed
    10
    Not completed
    2
         missing data at baseline
    1
         changes in confounding concomitant medication
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 12 12
    Age categorical
    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)
    		 12 12
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    before conversion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study participants, who entered the final analysis. Of 12 subjects, who entered the study, one subject was excluded due to missing data at baseline and one subject was excluded due to changes in confounding concomitant medication

    Subject analysis set title
    after conversion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study participants, who entered the final analysis. Of 12 subjects, who entered the study, one subject was excluded due to missing data at baseline and one subject was excluded due to changes in confounding concomitant medication

    Subject analysis sets values
    		 before conversion after conversion
    Number of subjects
    10
    10
    Age categorical
    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)
    10
    10
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Units: Subjects
        Female
    2
    2
        Male
    8
    8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    CyA Sandimmun capsules
    Reporting group description
    		 to twice daily oral CyA (Sandimmun capsules, Novartis GmBH)

    Subject analysis set title
    before conversion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study participants, who entered the final analysis. Of 12 subjects, who entered the study, one subject was excluded due to missing data at baseline and one subject was excluded due to changes in confounding concomitant medication

    Subject analysis set title
    after conversion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    study participants, who entered the final analysis. Of 12 subjects, who entered the study, one subject was excluded due to missing data at baseline and one subject was excluded due to changes in confounding concomitant medication

    Primary: difference in OGIS

    		 Close Top of page
    End point title
    		 difference in OGIS
    End point description
    End point type
    Primary
    End point timeframe
    at baseline and after three months
    End point values
    		 before conversion after conversion
    Number of subjects analysed
    10
    10
    Units: mL/min/m2
        median (inter-quartile range (Q1-Q3))
    422.17 (370.82 to 441.92)
    468.80 (414.27 to 488.57)
    Statistical analysis title
    		 Primary
    Statistical analysis description
    Considering insulin sensitivity as the primary endpoint, a post-hoc analysis found that a sample size of 10 had 99% power to detect a difference in OGIS of 47 ml min-1m-2, with a stan- dard deviation of 31 using a paired t-test with a 0.05 two-sided significance level
    Comparison groups
    before conversion v after conversion
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 SAS Enterprise Guide
    Confidence interval

    Primary: HCV-PCR

    		 Close Top of page
    End point title
    		 HCV-PCR
    End point description
    End point type
    Primary
    End point timeframe
    at baseline and after three months
    End point values
    		 before conversion after conversion
    Number of subjects analysed
    10
    10
    Units: copies/mL
        median (inter-quartile range (Q1-Q3))
    546000 (351750 to 2965000)
    2560000 (798000 to 3370000)
    Statistical analysis title
    		 Primary
    Statistical analysis description
    study participants, who entered the final analysis. Of 12 subjects, who entered the study, one subject was excluded due to missing data at baseline and one subject was excluded due to changes in confounding concomitant medication
    Comparison groups
    before conversion v after conversion
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.285
    Method
    		 SAS Enterprise Guide
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    during control visits, at least once monthly
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Study population

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    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: There was no non-serious adverse event

    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 Apr 19 15:47:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA