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    Summary
    EudraCT Number:2012-003535-27
    Sponsor's Protocol Code Number:1241.36
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-19
    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 number2012-003535-27
    A.3Full title of the trial
    A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon
    Studio clinico di fase III, randomizzato, parzialmente in doppio cieco e controllato verso placebo di BI 207127 in combinazione con Faldaprevir e Ribavirina per epatite cronica C genotipo 1 in una popolazione estesa di pazienti naive che include quelli non adatti ad assumere interferone peghilato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for testing efficacy and safety of BI 207127 in combination with Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCV Infection who received no previous medication, incl. patients that cannot receive peginterferon
    Studio clinico di BI 207127 in combinazione con Faldaprevir e Ribavirina per epatite cronica C genotipo 1 in una popolazione estesa di pazienti naive che include quelli non adatti ad assumere interferone peghilato.
    A.4.1Sponsor's protocol code number1241.36
    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 SponsorBOEHRINGER ING.
    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 supportBoehringer Ingelheim italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 No
    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 nameBI 207127 NA / 200mg
    D.3.2Product code BI 207127
    D.3.4Pharmaceutical form Film-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.3.9.2Current sponsor codeBI 207127
    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.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 No
    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 nameFaldaprevir / 120mg
    D.3.2Product code BI 201335 NA
    D.3.4Pharmaceutical form Capsule, soft
    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 INNfaldaprevir
    D.3.9.2Current sponsor codeBI 201335 NA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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: 3
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    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.3.4Pharmaceutical 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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic infection with HCV - genotype 1
    epatite C cronica genotipo 1.
    E.1.1.1Medical condition in easily understood language
    Chronic infection with Hepatitis C virus
    epatite C cronica
    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 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to confirm efficacy and safety of treatment with
    600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir
    (FDV) and ribavirin (RBV) for 16 or 24 weeks in "target" chronically
    infected HCV genotype 1 (GT1) treatment naïve patients, including
    patients with compensated cirrhosis. This "target" population excludes
    GT1a infected patients with the host IL28B rs12979860 CT or TT (non-
    CC) genotypes.
    The primary objective is to determine if there is a clinically meaningful
    difference between 16- and 24-week treatment durations.
    Lo scopo dello studio e' confermare l'efficacia e la sicurezza di un trattamento con BI 201227 600mg BID in combinazione con Faldaprevir (BI 2013335) 120mg QD e Ribavirina per 16 e 24 settimane, in pazienti naive affetti da epatite C cronica genotipo 1 (1b oppure 1a, 1a/b, 1 con sottotipo non definito e IL28B CC), incluso pazienti con cirrosi compensata.
    L'obiettivo primario e' determinare se c'e' una differenza clinicamente significativa tra le 16 e le 24 settimane di trattamento.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine if a minimum historical target
    Sustained Virologic Response (SVR) rate at 12 weeks of 71% for
    peginterferon (PegIFN) eligible patients and 50% for PegIFN-ineligible
    patients can be achieved by the combination treatments of BI 207127,
    FDV and RBV in target GT1 patients, including patients with
    compensated cirrhosis.
    L'obiettivo secondario e' determinare se il minimo storico del tasso di risposta virologica sostenuta a 12 settimane di 71% e 50%, rispettivamente in pazienti adatti e non adatti ad assumere Interferone Peghilato (PegIFN), puo' essere ottenuta dalla triplice terapia di combinazione con BI 207127, Faldaprevir e Ribavirina nella popolazione selezionata per questo studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Chronic hepatitis C infection, diagnosed by positive anti-HCV
    antibodies and detected HCV RNA at screening in addition to at least one
    of the following:
    a. positive anti-HCV antibodies or detected HCV RNA at least 6 months
    prior to screening, or
    b. liver biopsy indicating chronic HCV infection, or
    c. history of elevated alanine aminotransferase (ALT) levels at least 6
    months prior to screening.
    2. HCV infection of:
    a. sub-GT1b confirmed by genotypic testing at screening; or,
    b. sub-GT1a, GT1(with undefined subtype), or mixed sub-GT1a/1b
    confirmed by genotypic testing at screening in patients with IL-28b CC
    genotype.
    3. HCV viral load >= 1,000 IU/mL at randomisation.
    4. Patients who have never been previously treated with interferon
    alone, interferon+RBV, PegIFN+RBV or PegIFN+RBV+an
    investigational/approved DAA or any other HCV treatment regimen.
    5. Results of the IL-28b genotyping (rs12979860 polymorphism) at
    randomisation.
    6. Availability of a liver biopsy within 3 years or fibroscan within 6
    months prior to randomisation.
    7. Age 18 to 75 years (inclusive).
    8. Female patients:
    a. with documented hysterectomy,
    b. who have had both ovaries removed,
    c. with documented tubal ligation,
    d. who are post-menopausal with last menstrual period at least 12
    months prior to screening, or
    e. of childbearing potential with a negative serum pregnancy test at
    screening and Day 1, who, if sexually active, agree to use two nonhormonal
    methods of birth control from the date of screening until 7
    months after the last dose of RBV. Patients must agree not to breastfeed
    at any time from the date of screening until 7 months after the last
    dose of RBV. Accepted methods of contraception in the study include
    diaphragm with spermicidal substance, cervical caps, intrauterine
    devices and condoms. Note: Systemic hormonal contraceptives may not
    be as effective in women taking BI 207127/FDV combination therapy
    and are not accepted methods of contraception in the study.
    OR
    Male patients:
    a. who are documented to be sterile, or
    b. who are without pregnant female partner(s) and consistently and
    correctly use a condom while their female partner(s) (if of child-bearing
    potential) use one of the appropriate medically accepted methods of
    birth control from the date of screening until 7 months after the last
    dose of RBV. It is in the responsibility of the male patient to ensure that
    his partner(s) is not pregnant prior to screening into the study or
    becomes pregnant during the treatment and the observation phase.
    Female partners of childbearing potential should perform monthly
    pregnancy tests from the date of screening until 7 months after the last
    dose of RBV (tests will be provided by the sponsor).
    9. Signed informed consent form prior to trial participation
    1. Infezione cronica da HCV diagnosticata per sieropositivita' agli anticorpi anti-HCV e rilevamento di HCV-RNA allo screening in aggiunta ad almeno 1 dei seguenti criteri:
    a) sieropositivita' agli anticorpi anti-HCV o rilevamento di HCV-RNA almeno sei mesi prima dello screening oppure
    b) biopsia epatica consistente con infezione cronica da HCV, oppure
    c) storia di elevati livelli di ALT nei sei mesi precedenti lo screening;
    2. Infezione da HCV genotipo 1b oppure genotipo 1a, 1 non definito, misto 1a/1b (con genotipo Il28B CC), confermata dal test del genotipo allo screening;
    3. HCV-RNA &gt;= 1.000 UI/ml alla randomizzazione;
    4. Pazienti che non hanno mai ricevuto terapia con Interferone, PegIFN/RBV oppure PegIFN/RBV piu' un DAA gia' approvato oppure ancora sperimentale;
    5. Risultati disponibili del genotipo IL28B alla randomizzazione;
    6. Documentazione di biopsia epatica effettuata nei 3 anni o Fibroscan nei 6 mesi antecedenti la randomizzazione (se la cirrosi e' stata diagnosticata mediante una biopsia effettuata piu' di tre anni prima dello screening, la biopsia non deve essere ripetuta. Le biopsie o il test con Fibroscan possono non essere effettuati se controindicati per il paziente, l'inclusione nello studio sarà discussa con lo sponsor;
    7. Eta' compresa tra i 18 e i 75 anni (inclusi);
    8. Pazienti di sesso femminile:
    a) con isterectomia documentata, oppure
    b) con rimozione di entrambe le ovaie, oppure
    c) con legatura delle tube documentata, oppure
    d) in post-menopausa (ultima mestruazione 12 mesi prima dello screening), oppure
    e) in eta' fertile con un test di gravidanza su siero negativo allo screening e al giorno 1 che, se sessualmente attive, acconsentano ad utilizzare un metodo contraccettivo clinicamente accettato (diaframma con spermicida, spirale intrauterina, cappuccio cervicale e preservativo) dallo screening fino ad almeno 7 mesi dopo l'ultima dose di Ribavirina, oltre all’uso sistematico e corretto del preservativo da parte del partner. La paziente inoltre acconsente a non allattare dallo screening fino a 7 mesi dopo l'ultima dose di Ribavirina. I contraccettivi ormonali sistemici potrebbero non essere efficaci se assunti con la combinazione BI 207127 e Faldaprevir, non sono quindi considerati come metodo di contraccezione accettato durante la partecipazione alla sperimentazione;
    Pazienti di sesso maschile che:
    a) sono sterili (sterilita' documentata),
    b) non hanno una partner incinta e usano sistematicamente e in modo corretto il preservativo, mentre le loro partner femminili, se in eta' fertile, usano un metodo di contraccezione clinicamente accettabile dallo screening fino ad almeno 7 mesi dopo l'ultima dose di Ribavirina. E' responsabilita' del paziente assicurarsi che la partner non sia incinta prima della visita di screening e che non subentri una gravidanza durante lo studio e nel periodo di osservazione successivo. Le partner in età fertile dovranno sottoporsi a un test di gravidanza mensile dalla visita di screening fino a 7 mesi dopo l'ultima dose di Ribavirina (i test saranno forniti dallo sponsor dello studio);
    9. Consenso informato firmato in conformita' alle GCP e alle normative locali prima della partecipazione alla sperimentazione.
    E.4Principal exclusion criteria
    1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic
    testing at screening.
    2. HCV infection of sub-GT1a in patients with IL-28b CT or TT (non-CC
    polymorphisms).
    3. Liver disease due to causes other than chronic HCV infection which
    may include but is not limited to hemochromatosis, Wilson's disease, or
    autoimmune liver diseases. Note: patients with steatosis as part of the
    histological findings of the liver biopsy are not excluded.
    4. HIV infection.
    5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
    6. Confirmed or suspected active malignancy or history of malignancy
    within the last 5 years prior to screening (with an exception of
    appropriately treated basal cell carcinoma of the skin or in situ
    carcinoma of the uterine cervix).
    7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
    8. Subject is not willing to comply with the precautionary measures to
    prevent photosensitivity (avoid excessive sun exposure and use sun
    block on a daily basis).
    9. A condition that is insufficiently diagnosed, treated or clinically
    unstable which in the opinion of investigator may put the patient at risk
    because of participation in this study, influence the results of this study,
    or limit the patient's ability to participate in this study, including but not
    limited to severe chronic obstructive pulmonary disease, uncontrolled
    psychiatric disease.
    10. Decompensated liver disease, or history of decompensated liver
    disease, as evidenced by ascites, hepatic encephalopathy, history of
    esophageal variceal bleeding, or any other evidence of previous
    decompensation.
    11. Total bilirubin >2 mg/dL with ratio of direct/indirect >1.
    12. Serum albumin <=3.5 g/dL.
    13. Prothrombin time Institutional Normalised Ratio (INR) >=1.7.
    14. Clinical evidence of unstable cardiovascular disease which may
    further decompensate due to anemia, including unstable angina, recent
    myocardial infarction, cardiomyopathy, congestive heart failure,
    uncontrolled hypertension or significant arrhythmia.
    15. Red blood cell (RBC) disorders which include but are not limited to:
    thalassemia major, sickle cell anemia or G6PD deficit. Patients with
    traits or minor diseases (e.g. sickle cell trait or thalassemia minor) may
    be enrolled if the disease did not result in anemia at screening,
    according to the investigator's clinical judgment.
    16. Body weight <40 kg or >125 kg.
    17. Usage of any investigational drugs within 28 days prior to
    randomisation, or planned usage of an investigational drug during the
    course of this study.
    18. Received concomitant hematopoietic growth factor within 28 days
    prior to enrolment.
    19. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or
    any medication listed in a restricted medication list provided in ISF
    within 28 days prior to randomisation, with the exception of parenteral
    analgesics used during liver biopsy procedure.
    20. Known hypersensitivity to any ingredient of the study drugs.
    21. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and
    <=100 ng/mL, patients may be included if there is no evidence of liver
    cancer in an appropriate imaging study (e.g., ultrasound, computer
    tomography (CT) scan, or Medical Resonance Imaging (MRI)) within last
    6 months prior to randomization.
    22. Haemoglobin <11 g/dL for women and <12 g/dL for men.
    23. Absolute neutrophil count <1,000 cells/mm3.
    24. Platelet count <70,000 cells/mm3.
    1. Infezione da HCV di genotipo misto (1/2, 1/3, e 1/4) diagnosticata con test del genotipo allo screening;
    2. Infezione da HCV di genotipo1a con polimorfismo IL28B CT o TT;
    3. Evidenza di malattia epatica non imputabile all'infezione cronica da HCV, inclusa ma non limitata a emocromatosi, malattia di Wilson o malattie epatiche autoimmuni; la steatosi diagnosticata durante la biopsia non rappresenta un criterio di esclusione;
    4. Co-infezione da HIV;
    5. Infezione da epatite B (HBV) con HbsAg positivo;
    6. Presenza o sospetta presenza di tumore maligno presente o passato, negli ultimi 5 anni prima dello screening, ad eccezione di basalioma della cute o carcinoma della cervice in situ opportunamente trattati;
    7. Anamnesi di abuso etilico o abuso di droghe illecite (ad eccezione della cannabis) negli ultimi 12 mesi prima della randomizzazione;
    8. Rifiuto di seguire le misure precauzionali per prevenire la fotosensitivita';
    9. Presenza di una condizione non sufficientemente diagnosticata, trattata o clinicamente instabile che, secondo lo sperimentatore, potrebbe mettere a rischio il paziente, interferire con la capacita' del paziente a partecipare allo studio oppure influenzarne i risultati, compreso ma non limitato a una severa bronco-pneumopatia cronica ostruttiva e a malattie psichiatriche non controllate;
    10. Patologia epatica scompensata presente o passata, come evidenziato da ascite, encefalopatia epatica, precedenti episodi di sanguinamento delle varici esofagee o qualsiasi altra evidenza di una precedente scompensazione;
    11. Bilirubina totale &gt;2mg/dL con rapporto diretta/indiretta &gt;1;
    12. Albumina serica &lt;= 3.5 g/dL;
    13. Tempo di protrombina INR &gt;= 1.7;
    14. Evidenza clinica della presenza di una malattia cardiovascolare instabile che potrebbe scompensare, a seguito di anemia, includendo angina instabile, recente infarto miocardico, cardiomiopatia, insufficienza cardiaca congestizia, ipertensione arteriosa non controllata o aritmia significativa;
    15. Emoglobinopatie che includono ma non sono limitate a talassemia maggiore, anemia falciforme, o deficienza di G6PD. Pazienti portatori sani o con malattie di grado minore (portatori sani dell'anemia falciforme o talassemia minore) possono essere inclusi se la malattia non determina anemia allo screening, in accordo al giudizio dello sperimentatore;16. Peso corporeo &lt; 40 kg o &gt;125 kg;
    17. Utilizzo di farmaco sperimentale nei 28 giorni prima della randomizzazione o prevista somministrazione di farmaco sperimentale durante il periodo di partecipazione a questo studio;
    18. Utilizzo di fattori di crescita emopoietici nei 28 giorni prima dello screening;
    19. Terapia con silimarina (cardo mariano), glicirrizina o sho-saiko-to (integratore tradizionale giapponese a base di erbe) o qualsiasi altro farmaco elencato nella lista dei farmaci non permessi da protocollo nei 28 giorni antecedenti la randomizzazione, con eccezione degli analgesici parenterali usati durante la biopsia epatica;
    20. Ipersensibilita' conosciuta a uno dei componenti dei farmaci dello studio;
    21. Valore di alfa fetoproteina &gt;100ng/mL allo screening; se il valore e' &gt;20 e &lt;= 100 l'inclusione e' accettabile se non c'e' evidenza di cancro epatico, documentata dai risultati di test strumentali nei 6 mesi precedenti la randomizzazione;
    22. Emoglobina &lt;11 g/dl (donne) e &lt;12 g/dl (uomini);
    23. Conta assoluta dei neutrofili &lt;1.000 cellule/mm3;
    24. Piastrine &lt;70.000 cellule/mm3;
    E.5 End points
    E.5.1Primary end point(s)
    Sustained Virologic Response at Week 12 post-treatment (SVR12):
    Plasma HCV RNA level <25 IU/mL at 12 weeks after EOT
    Il parametro primario e' la risposta virologica sostenuta dopo 12 settimane dall'interruzione del trattamento, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 12 settimane dopo la durata pianificata del trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after EOT
    12 settimane dopo la durata pianificata del trattamento
    E.5.2Secondary end point(s)
    1. SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT
    2. SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT
    -risposta virologica dopo 24 settimane dall'interruzione del trattamento, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 24 settimane, dopo la durata pianificata del trattamento; -risposta virologica dopo 4 settimane dall'interruzione del trattamento, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 4 settimane, dopo la durata pianificata del trattamento;
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 4 weeks after end of treatment
    2. 24 weeks after end of treatment
    -dopo 24 settimane dall'interruzione del trattamento attivo e -dopo 4 settimane dall'interruzione del trattamento attivo
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    gruppi 1 e 2: doppio cieco, controllato verso placebo - gruppo 3: in aperto
    Arms 1 and 2: double-blind, placebo-controlled, Arm 3 open
    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 trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Republic of
    New Zealand
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last follow up Visit of the last patient undergoing the trial
    Last follow up Visit of the last patient 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 months34
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months34
    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.1.1Number 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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 447
    F.4.2.2In the whole clinical trial 835
    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
    non previsto
    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 Decision2012-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-11
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