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    Summary
    EudraCT Number:2015-005453-13
    Sponsor's Protocol Code Number:EGRADICATE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-04
    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 number2015-005453-13
    A.3Full title of the trial
    PILOT STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF GRAZOPREVIR + ELBASVIR FOR 12 OR 16 WEEKS IN LIVER TRANSPLANT RECIPIENTS
    “ESTUDIO PILOTO PARA EVALUAR LA EFICACIA Y TOLERABILIDAD DE GRAZOPREVIR + ELBASVIR DURANTE 12 O 16 SEMANAS EN RECEPTORES DE TRASPLANTE HEPÁTICO”.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PILOT STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF GRAZOPREVIR + ELBASVIR FOR 12 OR 16 WEEKS IN LIVER TRANSPLANT RECIPIENTS
    “ESTUDIO PILOTO PARA EVALUAR LA EFICACIA Y TOLERABILIDAD DE GRAZOPREVIR + ELBASVIR DURANTE 12 O 16 SEMANAS EN RECEPTORES DE TRASPLANTE HEPÁTICO”.
    A.3.2Name or abbreviated title of the trial where available
    EGRADICATE
    EGRADICATE
    A.4.1Sponsor's protocol code numberEGRADICATE
    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 SponsorFundació clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMSD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic. Hospital clinic de Barcelona
    B.5.2Functional name of contact pointCTU Clinic-Farmacologia Clinica
    B.5.3 Address:
    B.5.3.1Street AddressRosello 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754009838
    B.5.5Fax number+34932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 Zepatier (Tablets: 50 mg elbasvir and 100 mg grazoprevir)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited.Herford Road, Hoddesdon Hertforeside EN11 9BU Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product namezepatier tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElbasvir
    D.3.9.3Other descriptive nameELBASVIR
    D.3.9.4EV Substance CodeSUB174125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgrazoprevir
    D.3.9.3Other descriptive nameGRAZOPREVIR
    D.3.9.4EV Substance CodeSUB174126
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.9Recombinant medicinal product No
    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 No
    D.IMP: 2
    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 Copegus (Ribavirine 200 mg coated tablets)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Farma, S.A . Calle eucapilto, nº 33 28016 Madrid.
    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.3.1Product namecopegus
    D.3.2Product code ribavirine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNribavirin
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000 to 1200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.9Recombinant medicinal product No
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HCV infection and liver trasplant
    infección po VHC en pacientes recientemente trasplantados hepaticos
    E.1.1.1Medical condition in easily understood language
    HCV infection and liver trasplant
    infección po VHC en pacientes recientemente trasplantados hepaticos
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10024716
    E.1.2Term Liver transplantation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy and tolerability of Grazoprevir and Elbasvir in liver transplant recipients with hepatitis C recurrence.
    El objetivo principal del estudio evaluar la eficacia (respuesta viral sostenida a 12 semanas tras la finalización del tratamiento, RVS12) de la combinación de Grazoprevir + Elbasvir ± Ribavirina en receptores de trasplante hepático
    E.2.2Secondary objectives of the trial
    - To evaluate the beneficial effect of antiviral therapy in liver function.
    - To assess the impact of therapy in kidney function.
    Los objetivos secundarios estudiar la RVS 4 y 24, la tolerabilidad del tratamiento, y el impacto del tratamiento en la función hepática y función renal de los pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 18 and 78 year-old.
    - Previous liver transplantation (more than 6 months).
    - Genotype 1 and 4 infection.
    - Hepatitis C recurrence defined by the presence of abnormal liver function tests, positive HCV-RNA, histological signs of hepatitis C recurrence.
    - Viral load ≥ 10000 UI/mL.
    - Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10mg/d).
    - Treatment naïve or treatment experienced (Peg-RBV or triple therapy)
    - Edad entre 18 y 78 años.
    - Trasplante hepático (> 6 meses)
    - Infección por genotipo 1 o 4
    - Recidiva de la hepatitis C tras el trasplante definida como: pruebas hepaticas anormales, ARN-VHC positive, o signos histológicos de recidiva de la hepatitis C.
    - Carga viral del VHC >10000 UI/ml
    - Inmunosupresión con tacrolimus y/o micofenolato (se permite dosis baja de prednisona, ≤10mg/d).
    E.4Principal exclusion criteria
    - Genotype 2, 3, 5 or 6 infection.
    - Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
    - Hepatocellular carcinoma after liver transplantation.
    - Total bilirubin > 3 mg/dL.
    - Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
    - Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
    - Platelets < 75 x 109 cells/L.
    - Neutrophil count < 0.5 x 109 cells/L.
    - Hemoglobin < 9 g/dL.
    - Albumin < 3g/dL.
    - HIV infection.
    - Hepatitis B infection.
    - Active intake of toxic amounts of alcohol or recreational drugs.
    - Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
    - Intake of disallowed medications including(but not limited to):
    1. Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
    2. Antifungals: itraconazole, ketoconazole, voriconazole
    3. Antihypertensives: nifedipine
    4. Anticonvulsants: carbamazepine, phenytoin, phenobarbital
    5. Bosentan
    6. Modafinil
    7. St.Jonh’s Wort
    8. Immunosuppressants: cyclosporin, everolimus, sirolimus
    9. Diabetes agents: glibenclamide, glyburide
    10. Lipid lowering agents: gemfibrozil
    11. Eltrombopag
    12. Lapatinib
    13. HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
    14. Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
    - Cirrosis descompensada
    - Carcinoma hepatocelular de aparición tras el trasplante hepático.
    - Bilirrubina total > 3 mg/dL.
    - Inmunosupresión con Ciclosporina o in inhibidor de mTOR (everolimus o sirolimus).
    - Enfermedad extra-hepática grave: cardiovascular, respiratoria, cerebrovascular o diabetes mellitus mal controlada..
    - Plaquetas < 75 x 109/L.
    - Neutrófilos < 0.5 x 109 cells/L.
    - Hemoglobina < 9 g/dL.
    - Albúmina < 3 g/L.
    - Infección por VIH o hepatitis B.
    - Ingesta active de drogas o alcohol.
    - Mujeres en embarazo o lactancia, o hombres con pareja en embarazo o lactancia.
    - Ingesta de medicamentos prohibidos. incluidos:
    1.Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
    2. Antifungals: itraconazole, ketoconazole, voriconazole
    3. Antihypertensives: nifedipine
    4. Anticonvulsants: carbamazepine, phenytoin, phenobarbital
    5. Bosentan
    6. Modafinil
    7. St.Jonh’s Wort
    8. Immunosuppressants: cyclosporin, everolimus, sirolimus
    9. Diabetes agents: glibenclamide, glyburide
    10. Lipid lowering agents: gemfibrozil
    11. Eltrombopag
    12. Lapatinib
    13. HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
    14. Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
    E.5 End points
    E.5.1Primary end point(s)
    6.2. Primary end point:
    Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment week 12.
    Primario:
    respuesta viral sostenida a 12 semanas tras la finalización del tratamiento, RVS12) de la combinación de Grazoprevir + Elbasvir ± Ribavirina en receptores de trasplante hepático
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment week 12.
    Indetectabilidad del VHC-RNA en la semana º12 post tratamiento
    E.5.2Secondary end point(s)
    - To evaluate the beneficial effect of antiviral therapy in liver function.
    - To assess the impact of therapy in kidney function.
    Los objetivos secundarios estudiar la RVS 4 y 24, la tolerabilidad del tratamiento, y el impacto del tratamiento en la función hepática y función renal de los pacientes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Sustained virological response 4 (SVR4) and 24 (SVR24) defined as HCV-RNA undetectable at post-treatment weeks 4 and 24, respectively.
    - Effects of antiviral therapy on renal function.(cleareance de creatinine)
    - Effects of antiviral therapy in liver function.(transaminases)
    - Tolerability of this combination in liver transplant recipients.
    - porcentaje de indetectabilidad para RNA-VHC en la semama 4 y 24 post tratamiento
    -Efectos del tratamiento en la funcion renal (cleareance de creatinina)
    - efectos del tratamiento en la función hepática (transaminasas)
    - tolerancia de la combinación del tratamiento en pacientes ttrasplantados hepárticos
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-07-04. Yes
    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 state30
    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)
    none
    no
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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