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   43865   clinical trials with a EudraCT protocol, of which   7286   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

    Print Download

    Summary
    EudraCT Number:2010-019505-42
    Sponsor's Protocol Code Number:LEG-SIL-LTX-03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-04-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-019505-42
    A.3Full title of the trial
    ESTUDIO ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LEGALON SIL EN EL TRATAMIENTO DE LA RECURRENCIA DE VHC EN EL INJERTO DE PACIENTES SOMETIDOS A UN TRASPLANTE ORTOTÓPICO DE HÍGADO / A randomized, double-blind, placebo controlled, study to investigate the efficacy and safety of Legalon SIL for the treatment of HCV recurrence of the graft in orthotopic liver transplant patients
    A.4.1Sponsor's protocol code numberLEG-SIL-LTX-03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRottapharm SpA
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSILIBININA SUCCINATO SODIO
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameSILIBININA SUCCINATO SODIO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeExtracto de la planta Silibum marianum / Silibum marianum plant extract
    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 placeboSolution for infusion
    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
    Pacientes de 18-70 años afectados por VHC en espera de de un trasplante ortotópico de hígado / 18-70 years old patients affected by HCV awaiting orthotopic liver transplantation
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si el tratamiento con Legalon SIL es efectivo para prevenir la reinfección por VHC en pacientes crónicamente infectados por hepatitis C durante un periodo de 6 meses después de un TOH / To determine if treatment with Legalon SIL is effective in preventing HCV re-infection in chronically infected hepatis C patients over a period of 6 months after OLT
    E.2.2Secondary objectives of the trial
    Determinar si Legalon SIL es capaz de inducir una respuesta virológica / To determine if Legalon SIL is able to induce a virological response
    Determinar la seguridad y tolerabilidad de Legalon SIL / To determine the safety and tolerability of Legalon SIL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. El paciente debe proporcionar su consentimiento informado, con firma y fecha, antes de ser sometido a cualquier procedimiento relacionado con el ensayo.
    2. Paciente entre 18 y 70 años de edad.
    3. El paciente debe poseer una infección por VHC documentada. El resultado para ARN-VHC obtenido en el laboratorio local en la visita de selección debe confirmar unos valores de ARN-VHC > 1000 IU/mL.
    4. En el momento de la selección, el paciente debe ser candidato a un trasplante hepático de acuerdo con los criterios MELD.
    5. El paciente debe poseer un diagnóstico documentado de cirrosis.
    6. Peso del paciente entre 50 kg y 100 kg.
    7. Los pacientes deben tener capacidad para comunicarse, participar y cumplir con los requisitos de todo el estudio.
    8. Las pacientes en edad fértil deben estar de acuerdo en utilizar un método anticonceptivo (anticonceptivos orales, DIU, parche anticonceptivo transdérmico) y en el momento de la selección deben tener un resultado negativo en la prueba de embarazo en orina.
    9. En los 6 meses previos a la selección, o entre la selección y el Día 1, los pacientes con historia de diabetes o hipertensión se les debe realizar el genotipo para VHC, radiografía de tórax, ultrasonografía y exploración ocular. En los 3 meses previos a la selección, se debe realizar un ECG de 12 derivaciones.
    /
    1. Patient must provide signed and dated informed consent before undergoing any trial related procedure.
    2. Patient between 18 and 70 years of age.
    3. Patient must have documented HCV infection. The HCV-RNA result obtained from the local laboratory at the screening visit must confirm HCV-RNA > 1000 IU/mL.
    4. Patient must qualify for liver transplantation at the time of Screening according to MELD criteria
    5. Patient must have a documented diagnosis of cirrhosis.
    6. Patient weigh between 50 kg and 100 kg.
    7. Patients must be able to communicate, participate and comply with the requirements of the entire study.
    8. Female patients of child-bearing potential must agree on using a contraceptive method (oral contraceptive, IUD, transdermal contraceptive patch) and must have a negative pregnancy urine test at screening.
    9. HCV Genotype, chest X-ray, ultrasonography and ocular examination (for patients with history of diabetes or hypertension) must be performed within 6 months prior to Screening or between Screening and Day 1. 12-Lead ECG must be performed within 3 months prior to Screening.
    E.4Principal exclusion criteria
    1. Pacientes con coinfección conocida por el virus de inmunodeficiencia humana (VIH) o de la hepatitis B (HBsAg positivo).
    2. Infecciones sépticas activas en el momento de la selección.
    3. Trasplante de órganos previo, distinto del de córnea o pelo.
    4. Uso de inmunosupresores sistémicos o de agentes inmunomoduladores (incluyendo corticoides sistémicos) en las 4 semanas previas a la visita de selección o durante el periodo de selección.
    5. Tratamiento para el VHC con cualquier terapia en investigación (el uso previo de silimarina no es excluyente).
    6. Tratamiento para el VHC con cualquier terapia autorizada, o terapia de mantenimiento previa con cualquier interferon alfa en los 30 días previos a la visita de aleatorización.
    7. Participación en cualquier otro ensayo clínico durante los 30 días previos a la aleatorización, o intención de participar en otro ensayo clínico durante la participación en este estudio.
    8. Cualquier condición médica conocida que pudiera interferir con la participación del sujeto en el estudio y con la finalización del mismo, incluyendo (aunque no limitado a):
    • Enfermedad pulmonar crónica (por ejemplo, enfermedad pulmonar obstructiva crónica, enfermedad pulmonar intersticial, fibrosis pulmonar, sarcoidosis).
    • Anomalías o disfunciones cardiacas clínicamente significativas o antecedentes de haberlas padecido (por ejemplo, angina, insuficiencia cardiaca congestiva, infarto de miocardio, hipertensión pulmonar, cardiopatía congénita compleja, cardiomiopatía, arritmia importante), incluyendo hipertensión actual no controlada o historia de uso de agentes antianginosos para afecciones cardiacas.
    •Cualquier otra condición que, en la opinión del médico-investigador, convierta al paciente en no apto para la inclusión o pudiera interferir con su participación en el estudio y la finalización del mismo.
    9. Sujetos que forman parte del personal directamente involucrado en este estudio, o familiares de los mismos.
    10. En las mujeres, el embarazo o la lactancia.
    11. Hipersensibilidad conocida a Legalon® SIL.
    /
    1. Patients known to be co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
    2. Active septic infections at time of screening.
    3. Previous organ transplantation other than cornea and hair.
    4. Use of systemic immunosuppressant or immunomodulating agents (including systemic corticosteroids) within 4 weeks of the screening visit or during the screening period.
    5. Treatment for HCV with any investigational medication (prior use of silymarin is not exclusionary)
    6. Treatment for HCV with any licensed therapies or prior maintenance therapy with any interferon alpha within 30 days of the randomization visit.
    7. Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
    8. Any known pre-existing medical condition that could interfere with the subject’s participation in and completion of the study including but not limited to:
    • Chronic pulmonary disease (eg, clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis).
    • Current or history of any clinically significant cardiac abnormalities/dysfunction (eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension, or history of use of antianginal agents for cardiac conditions.
    • Any other condition which, in the opinion of a physician-investigator, would make the patient unsuitable for enrollment or could interfere with the subject participating in and completing the study.
    9. Subjects who are part of the site personnel directly involved with this study or those who are family members of the investigational study staff.
    10. If female, pregnancy or breast-feeding.
    11. Known hypersensitivity to Legalon® SIL.
    E.5 End points
    E.5.1Primary end point(s)
    Alcanzar una respuesta virológica sostenida (RVS), definida como una Respuesta Virológica (valores de ARN-VHC indetectables) que se mantiene durante 6 meses después del trasplante.
    /
    To achieve sustained virological response (SVR), defined as Virological Response (undetectable HCV-RNA) that lasts 6 months after the transplant
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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.8.5The 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    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 Decision2010-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
    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 Apr 29 04:04:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA