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    Summary
    EudraCT Number:2006-006263-23
    Sponsor's Protocol Code Number:ML20910
    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:2012-01-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006263-23
    A.3Full title of the trial
    Efficacy of Oseltamivir treatment in laboratory- confirmed influenza: evaluation of effect on viral shedding and on serum and cytoplasmatic inflammatory cytokine concentration.
    Efficacia del trattamento con Oseltamivir nell'influenza confermata in laboratorio: valutazione degli effetti sullo shedding virale e sulla concentrazione serica e citoplasmatica delle citochine infiammatorie.
    A.4.1Sponsor's protocol code numberML20910
    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 SponsorROCHE
    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 TAMIFLU
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule, hard
    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 INNOseltamivir
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number75
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Influenza type A and B virus infection
    Infezione da influenza virus tipo A e tipo B
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 assess the effect of treatment with Oseltamivir (Ro 64-0796) on viral shedding and on serum and cytoplasmatic inflammatory cytokine concentration.
    Valutare l’effetto del trattamento con Oseltamivir (Ro 64-0796) sullo shedding virale e sulla concentrazione serica e citoplasmatica delle citochine infiammatorie .
    E.2.2Secondary objectives of the trial
    • To assess a correlation between serum and cytoplasmatic inflammatory cytokine and clinical picture and viral shedding • To investigate the effect of treatment with Oseltamivir on patient’s health and functional status • To define the circulation of viral strains resistant to antivirals • To estimate the incidence of NI-resistant strains during treatment
    - Valutare la correlazione tra citochine infiammatorie seriche e citoplasmatiche, quadro clinico e shedding virale. - Analizzare gli effetti del trattamento con Oseltamivir sullo stato di salute e sui livelli di attivita' dei pazienti. - Definire la presenza di ceppi virali circolanti resistenti agli antivirali. - Stimare l’incidenza di ceppi resistenti agli Inibitori della Neuraminidasi (IN) durante il trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ambulatory male and female patients • Adults subjects between 18 to 64 years of age inclusive • Able to participate and willing to give written informed consent • Influenza -like illness (ILI) defined as follows: Sudden onset of the following symptoms: - fever >38°C AND - at least one of respiratory symptoms (i.e. cough, sore throat, coryza, etc.) AND - at least one systemic symptom (i.e. myalgia, fatigue , headhache , chills/sweat) • positive rapid assay for detection of influenza antigen
    Pazienti maschi e femmine domiciliari.
    Soggetti adulti(eta' compresa tra i 18 e i 64 anni compresi)
    In grado di acconsentire alla partecipazione allo studio firmando il consenso informato .
    Soggetti con Influenza like illness (ILI) , definita come :
    improvvisa comparsa dei seguenti sintomi :
    febbre &gt; 38°C
    E
    Almeno un sintomo respiratorio (per es tosse, mal di gola , raffreddore, etc)
    E
    Almeno un sintomo sistemico (per es mialgia, spossatezza, cefalea, brividi /sudorazioni. etc)
    Positivita' al test rapido per influenza- virus.
    E.4Principal exclusion criteria
    • Presentation later than 36 hours after the onset of symptoms.
    • Presenting with influenza-like symptoms outside an outbreak based on local surveillance activities.
    • Women who are lactating or pregnant.
    • Patients with uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis. For the purposes of this study uncontrolled is defined as disease requiring a change of drug therapy (including an increase in dose), or hospitalisation within four weeks prior to study day 1. In patient hospitalisation of less than 24 hours duration will be permitted.
    • Transplant patients or patients known to have HIV infection.
    • Patients who have received an investigational new drug within the 30 days prior to study day 1.
    • Influenza vaccination within November 2006 to January 2007

    • Allergy to oseltamivir or any excipients in the capsules of study medication (see protocol section 8.1)
    • Receipt of antiviral therapy (such as amantadine, rimantadine, zanamivir, ribavirin, interferon) or systemic steroids or immuno-suppressants within two weeks prior to study day 1.
    • A clinically relevant history of abuse of alcohol or other drugs
    Soggetti visti oltre le 36 ore dalla comparsa dei sintomi.
    Soggetti con ILI non facenti parti del programma di locale sorveglianza attiva della comparsa di epidemia influenzale nella comunita'.
    Donne in gravidanza o allattamento.
    Pazienti con rilevanti disordini ,clinicamente non controllati, a livello renale, cardiaco, polmonare , vascolare, neurologico (diabete, patologie tiroidee, malattie adrenergiche ) , disordini del sistema immunitario, cancro, epatiti, cirrosi. In questo studio si definiscono come non controllate quelle patologie che richiedono modifiche della terapia farmacologica (compreso l’aumento della dose) , o l’ospedalizzazione nelle 4 settimane precedenti il giorno 1 delo studio. E’ consentita l’ospedalizzazione per una durata inferiore alle 24 ore.
    Pazienti trapiantati o pazienti con infezione HIV.
    Pazienti che hanno ricevuto un farmaco sperimentale nei 30 giorni precedenti il giorno 1 dello studio.
    Vaccinazione contro l’influenza virus nel periodo compreso tra Novembre 2006 e Gennaio 2007.
    Allergia a Oseltamivir o a qualunque eccipiente della capsula del farmaco in studio(vd protocollo sez. 8.1).
    Terapia con farmaci antivirali (come amantadina, rimantadina, zanamivir, ribavirina, interferone ) o steroidi sistemici o immunosoppressori nelle 2 settimane precedenti il giorno 1 dello studio.
    Abuso di alcool o di altri farmaci.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoints are the times to return to normal health status and normal levels of activity
    I principali endpoints sono i tempi di ritorno al normale stato di salute e ai normali livelli di attivita'
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    terapia di supporto
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months6
    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.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state46
    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 Decision2006-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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