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   43871   clinical trials with a EudraCT protocol, of which   7290   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:
    Personal monitoring of liver transplant patients infected with Hepatitis C Virus. Pilot study to compare the evolution of Hepatitis C by receiving immunosuppression with tacrolimus in combination with Mycophenolate Mofetil or Everolimus.

    Summary
    EudraCT number
    		 2012-002105-22
    Trial protocol
    		 ES  
    Global end of trial date
    01 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2021
    First version publication date
    29 Nov 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EVL-VHC-HVH.12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Dra Itxarone Bilbao, VHIR, 0034 932746113, ibilbao@vhebron.net
    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
    01 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the evolution of hepatitis C recurrence as determined by progression of liver fibrosis (F ? 2, as ranked by ISHAK) a year post-liver transplantation in patients receiving low dose tacrolimus in combination with mycophenolate mofetil vs everolimus. Since recruitment of patients was imcomplete, the assay only comprised the study of viral populations. HCV genomes isolated from pre-LT and 15-day post-LT serum samples of ten patients, who underwent orthotopic LT, were quantified and sequenced using a next-generation sequencing platform. Sequence alignments, phylogenetic trees, quasispecies complexity measures, biostatistics analyses, adjusted R2 values, and analysis of variance (ANOVA) were carried out. Viral populations were then used as predictor of the future degree of liver damage.
    Protection of trial subjects
    This study was approved by the local institutional review board for clinical research, and all patients gave written informed consent in accordance with the 1975 Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Spain: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    8
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Ten patients were included in the study, five being infected with HCV genotype 1 subtype a (G1a), four with G1b, and one with G3a.

    Pre-assignment
    Screening details
    		 All patients were assigned to the single group in the study

    Period 1
    Period 1 title
    Pre-transplantation
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Liver transplantation
    Arm description
    		 -
    Arm type
    		 Single arm, no intervention

    Investigational medicinal product name
    No product was administered
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for...
    Routes of administration
    Unknown use
    Dosage and administration details
    There was no administration of products in this assay

    Number of subjects in period 1
    		Liver transplantation
    Started
    10
    Completed
    10
    Period 2
    Period 2 title
    Post-transplantation
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 No treatment
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		No treatment
    Started
    10
    Completed
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pre-transplantation
    Reporting group description
    		 -

    Reporting group values
    		 Pre-transplantation Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 8 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Liver transplantation
    Reporting group description
    		 -
    Reporting group title
    No treatment
    Reporting group description
    		 -

    Subject analysis set title
    Pre-LT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    10 patients with samples obtained6 weeks before liver transplantation

    Subject analysis set title
    Post-LT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    10 patients with samples taken 2 weeks after liver transplantation

    Primary: Hill D1

    		 Close Top of page
    End point title
    		 Hill D1
    End point description
    The following diversity index was used to define the viral quasispecies complexity at the molecular level: Hill numbers (see article)
    End point type
    Primary
    End point timeframe
    Overall study
    End point values
    		 Pre-LT Post-LT
    Number of subjects analysed
    10
    10
    Units: Units
        arithmetic mean (standard deviation)
    19.80 ± 12.85
    18.92 ± 11.03
    Statistical analysis title
    		 Hill D1
    Comparison groups
    Post-LT v Pre-LT
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Hill D2

    		 Close Top of page
    End point title
    		 Hill D2
    End point description
    End point type
    Primary
    End point timeframe
    15 days after liver transplantation
    End point values
    		 Pre-LT Post-LT
    Number of subjects analysed
    10
    10
    Units: units
        arithmetic mean (standard deviation)
    8.70 ± 5.53
    8.99 ± 6.86
    Statistical analysis title
    		 Hill D2
    Comparison groups
    Post-LT v Pre-LT
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.539
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Hill Dinf

    		 Close Top of page
    End point title
    		 Hill Dinf
    End point description
    End point type
    Primary
    End point timeframe
    15 days after transplantation
    End point values
    		 Pre-LT Post-LT
    Number of subjects analysed
    10
    10
    Units: units
        arithmetic mean (standard deviation)
    3.35 ± 1.23
    3.55 ± 2.18
    Statistical analysis title
    		 Hill Dinf
    Comparison groups
    Post-LT v Pre-LT
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.615
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    15 days after transplantation
    Adverse event reporting additional description
    There were no adverse events, since the assay only reached the phase of blood sampling, with no further treatments (they were suspended). Blood samples were taken in order to characterize VHC virus populations in each patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Post-LT
    Reporting group description
    		 -

    Serious adverse events
    		 Post-LT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (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
    		 Post-LT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (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: The assay only included blood sampling for VHC population study. There were no pharmacological interventions, contrary to what was initially proposed.

    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 of the viral complexity measures studied at 15 days after liver transplantation were significantly associated with liver damage progression at 1 year following the procedure. Full article available at: https://doi.org/10.3390/genes12111731
    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-Mon May 06 10:08:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA