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    Summary
    EudraCT Number:2010-020146-10
    Sponsor's Protocol Code Number:LEG-SIL-LTX-02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-020146-10
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LEGALON SIL FOR THE TREATMENT OF HCV RECURRENCE IN STABLE LIVER TRANSPLANTED PATIENTS.
    STUDIO RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO PER INDAGARE L'EFFICACIA E LA SICUREZZA DI LEGALON-SIL PER IL TRATTAMENTO DELLA REINFEZIONE DA HCV IN PAZIENTI STABILI DOPO ALMENO UN ANNO DAL TRAPIANTO DI FEGATO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LEGALON SIL FOR THE TREATMENT OF HCV RECURRENCE IN STABLE LIVER TRANSPLANTED PATIENTS.
    STUDIO RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO PER INDAGARE L'EFFICACIA E LA SICUREZZA DI LEGALON-SIL PER IL TRATTAMENTO DELLA REINFEZIONE DA HCV IN PAZIENTI STABILI DOPO ALMENO UN ANNO DAL TRAPIANTO DI FEGATO.
    A.4.1Sponsor's protocol code numberLEG-SIL-LTX-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorROTTAPHARM S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportROTTAPHARM S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROTTAPHARM S.P.A.
    B.5.2Functional name of contact pointDirezione scientifica
    B.5.3 Address:
    B.5.3.1Street Addressvia valosa di sopra, 9
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+390397390319
    B.5.5Fax number+390397390371
    B.5.6E-mailGiampaolo.Giacovelli@rottapharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Legalon-SIL
    D.2.1.1.2Name of the Marketing Authorisation holderRottapharm
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSilibinin-C-2’,3-dihydrogen succinate, disodium salt
    D.3.9.1CAS number 55254-34-7
    D.3.9.2Current sponsor code34501S
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HCV recurrence in stable liver transplanted patients not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care,SOC)
    Reinfezione da HCV in pazienti stabili dopo un anno dal trapianto di fegato che non hanno risposto alla terapia con peginterferone/ribavirina (terapia standard).
    E.1.1.1Medical condition in easily understood language
    HCV recurrence in stable liver transplanted patients not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care,SOC)
    Reinfezione da HCV in pazienti stabili dopo un anno dal trapianto di fegato che non hanno risposto alla terapia con peginterferone/ribavirina (terapia standard).
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.
    Determinare l'effetto del trattamento post trapianto con Legalon-SIL sulla viremia 30 giorni dopo l'inizio del trattamento.
    E.2.2Secondary objectives of the trial
    - To determine the effect of post-transplant treatment with Legalon SIL on lymphocyte activation during Short- and Long-Term follow up and HCV viral load one year after the beginning of treatment. - To determine the effect of post-transplant treatment with Legalon SIL on fibrosis and functional state. - To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.
    - Determinare l'effetto del trattamento post trapianto con Legalon-SIL sull'attivazione linfocitaria a breve (30 giorni dopo l'inizio del trattamento) e a lungo (1 anno dopo l'inizio del trattamento) termine e la viremia 1 anno dopo l'inizio del trattamento. - Determinare l'effetto del trattamento post trapianto con Legalon-SIL sulla fibrosi e sulla funzionalita' epatica. - Determinare la sicurezza e la tollerabilita' del trattamento post trapianto con Legalon-SIL, compresa la valutazione dell'effetto sui livelli dei farmaci immunomodulatori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with HCV recurrent chronic hepatitis after liver transplantation, not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care, SOC). - Stable (≥ 1 year) liver transplanted patients with HCV recurrence (as indicated by positive serum HCV-RNA, increase in transaminases, signs of graft damage according to HCV recurrence and/or presence of liver fibrosis as assessed by Fibroscan). - Patients without biochemical, clinical and/or histological suspicion of rejection.
    - Pazienti con reinfezione cronica da HCV dopo trapianto di fegato che non hanno risposto al trattamento con Peginterferone/Ribavirina (trattamento standard)- Pazienti stabili dopo almeno 1 anno dal trapianto di fegato, affetti da reinfezione da HCV (indicato dalla positivita' all’HCV-RNA, dall’incremento delle transaminasi, dai segni di danneggiamento dell’organo trapiantato mostrati dalla reinfezione da HCV e/o dalla presenza di fibrosi epatica valutata con Fibroscan). - Pazienti senza sospetti biochimici, clinici e/o istologici di rigetto.
    E.4Principal exclusion criteria
    - Patients with active hepatocellular carcinoma or other neoplasia. - Patients with active biliary tract anomalies. - Patients with a rejection episode in the 6 months preceding study inclusion. - Patients on active interferon treatment. - Patients with creatinine clearance < 50 ml.
    - Pazienti con carcinoma epatocellulare attivo o altre neoplasie. - Pazienti con anomalie attive delle vie biliari. - Pazienti con episodi di rigetto nei 6 mesi precedenti l'inclusione nello studio. - Pazienti in trattamento con interferone. - Pazienti con clearance della creatinina &lt;50 ml.
    E.5 End points
    E.5.1Primary end point(s)
    - HCV RNA at 30 days (end of the Short Term Follow-up)
    - HCV RNA a 30 giorni (fine del follow-up a breve termine)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 30 days after the beginning of study treatment
    a 30 giorni dall'inizio del trattamento
    E.5.2Secondary end point(s)
    - To determine the effect of post-transplant treatment with Legalon SIL on lymphocyte activation during Short- and Long-Term follow-up. - to determine the effect of post-transplant Legalon SIL on liver fibrosis, liver functional state, and HCV viral load one year after the beginning of treatment. - To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.
    - Determinare l'effetto del trattamento post trapianto con Legalon-SIL sull'attivazione linfocitaria a breve (30 giorni dopo l'inizio del trattamento) e a lungo (1 anno dopo l'inizio del trattamento) termine e la viremia 1 anno dopo l'inizio del trattamento. - Determinare l'effetto del trattamento post trapianto con Legalon-SIL sulla fibrosi e sulla funzionalita' epatica. - Determinare la sicurezza e la tollerabilita' del trattamento post trapianto con Legalon-SIL, compresa la valutazione dell'effetto sui livelli dei farmaci immunomodulatori.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at 30 days after the beginning of study treatment - at 1 year after the beginning of study treatment
    - 30 giorni dopo l'inizio del trattamento - 1 anno dopo l'inizio del trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Follow up
    Follow up
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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