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    Summary
    EudraCT Number:2015-000699-91
    Sponsor's Protocol Code Number:RACHE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-10
    Trial results View 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 number2015-000699-91
    A.3Full title of the trial
    Two treatment strategies with Ribavirin for Chronic Hepatitis E and severe acute forms randomized study
    Estudio aleatorizado de dos estrategias de tratamiento con Ribavirina para la Hepatitis Crónica E y formas agudas graves
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Two treatment strategies with Ribavirin for Chronic Hepatitis E and severe acute forms randomized study
    Estudio aleatorizado de dos estrategias de tratamiento con Ribavirina para la Hepatitis Crónica E y formas agudas graves
    A.4.1Sponsor's protocol code numberRACHE
    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 Hospital Vall Hebron Institut de Recerca
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Hospital Vall Hebron Institut de Recerca
    B.5.2Functional name of contact pointServicio Hepatología
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall Hebron
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934893000
    B.5.6E-mailresteban@vhebron.net
    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 Ribavirina Normon
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Normon S.A.
    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 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 INNRibavirina
    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 typeequal
    D.3.10.3Concentration number200
    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
    Chronic Hepatitis E
    Hepatitis Crónica E
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis E
    Hepatitis Crónica E
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10019768
    E.1.2Term Hepatitis E
    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
    Efficacy assessment (sustained virologic response rate) with Ribavirina in two therapeutic strategies with ribavirina in patients with chronic hepatitis E and severe acute.
    Valoración de la eficacia (tasa de respuesta virológica sostenida) del tratamiento con Ribavirina en dos estrategias terapéuticas con ribavirina en pacientes con hepatitis E crónica y aguda grave.
    E.2.2Secondary objectives of the trial
    - To define the recidiva real rate of the chronic hepatitis by a prospective 12 months trial.
    - Validation of Fibroscan as diagnostic test for the fibrosis in the chronic hepatitis E.
    - Identification of risk factors associated with chronic hepatitis E ( type of immunosuppression , analytical data , epidemiological factors ... ) .
    - To reduce costs derived from the control of the symptomatic hemolytic anemia in patients under treatment by the adjustment of Ribavirina's plasmatic levels and hemoglobin.
    - Study of the possible mutagenic effect of ribavirin in patients with chronic hepatitis E.
    - Definir la verdadera tasa de recidiva de la hepatitis crónica E mediante un estudio prospectivo y con un seguimiento de 12 meses.
    - Validación de la Elastografía de transición (Fibroscan) como test diagnóstico de fibrosis en la hepatitis crónica E.
    - Identificación de factores de riesgo asociados a la hepatitis crónica E (tipo de inmunosupresión, datos analíticos, factores epidemiológicos?).
    - Reducir los costes derivados del control de la anemia hemolítica sintomática en pacientes bajo tratamiento por medio del ajuste de dosis a niveles plasmáticos de Ribavirina y hemoglobina.
    - Estudio del posible efecto mutagénico de la Ribavirina en los pacientes con hepatitis crónica E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 years old or above.
    - That meet one of the following two diagnostics:
    a) chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated by an interval of six months determinations.
    b) Severe acute hepatitis E: ALT levels greater than 10 times the normal limit , HEV RNA positive , and signs of acute liver injury (INR > 1.5) ; or extrahepatic manifestations or liver failure in patients with previous liver disease.
    - Signed informed consent
    - Edad igual o superior a 18 años.
    - Que cumplan alguno de los siguientes dos diagnósticos:
    a) Hepatitis crónica E: RNA VHE detectable en pacientes con elevación de los niveles de transaminasas durante al menos 6 meses y/o RNA VHE detectable en 2 determinaciones separadas por un intervalo de 6 meses.
    b) Hepatitis aguda grave E: niveles de ALT superior a 10 veces el límite de la normalidad, con RNA VHE positivo, y signos de lesión hepática aguda (INR> 1.5); o con manifestaciones extrahepáticas o fallo hepático en pacientes con hepatopatía previa.
    - Firma del consentimiento informado
    E.4Principal exclusion criteria
    - Terminal illness with a life expectancy of less than six months.
    - Patients with contraindications for treatment with Ribavirin :
    a) Pregnancy or breastfeeding
    b) Hepatic serious insufficiency or unbalanced cirrhosis.
    c) Hemoglobinopathies ( thalassemia , sickle cell anemia ) .
    d) History of severe pre-existing cardiac disease , including unstable heart disease .
    - Enfermedad terminal, con una esperanza de vida esperada inferior a 6 meses.
    - Pacientes con contraindicación para el tratamiento con Ribavirina:
    a) Gestación o lactancia.
    b) Insuficiencia hepática grave o cirrosis descompensada.
    c) Hemoglobinopatías (Talasemia, anemia de células falciformes).
    d) Antecedente de Enfermedad cardíaca grave preexistente, incluida cardiopatía inestable.
    E.5 End points
    E.5.1Primary end point(s)
    Sustained virological response ( HEV RNA undetectable at 48 weeks after completion of treatment ) .
    Respuesta virológica sostenida (RNA VHE indetectable a las 48 semanas de haber finalizado el tratamiento).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 48 weeks after treatment ends .
    A las 48 semanas de haber finalizado el tratamiento.
    E.5.2Secondary end point(s)
    - Virological response at the end of treatment ( RNA undetectable at end of treatment with ribavirin HEV) .
    - Ribavirin dose titration according to drug plasma levels. Ribavirin plasma levels of each patient were recorded every 4 weeks
    - Respuesta virológica al final de tratamiento (RNA VHE indetectable al final de tratamiento con ribavirina).
    - Ajuste de dosis ideal de ribavirina según niveles plasmáticos de fármacos. Se registrarán los niveles plasmáticos de ribavirina de cada paciente cada 4 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 12 or 24 weeks depending on the group .
    - Every 4 weeks
    - A las 48 semanas de haber finalizado el tratamiento.
    - Cada 4 semanas.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 regimenes de ribavirina
    2 ribavirin regimens
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    LPLV
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state56
    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)
    Standard of care
    Práctica clínica habitual
    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 Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
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