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    Summary
    EudraCT Number:2012-003533-41
    Sponsor's Protocol Code Number:1241.20
    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:2012-10-26
    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 number2012-003533-41
    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 in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection
    Studio clinico di fase III, randomizzato, parzialmente in doppio cieco e controllato verso placebo di BI 207127 in combinazione con Faldaprevir e Ribavirina in pazienti naive affetti da epatite C cronica genotipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    studio clinico per testare l'efficacia e la sicurezza di BI 207127 in combinazione con Faldaprevir e Ribavirina in pazienti naive affetti da epatite C cronica genotipo 1
    A.4.1Sponsor's protocol code number1241.20
    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 S.p.A.
    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 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.3.8INN - 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
    Aim of the trial is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir (previously called BI 201335) and RBV for 16 and 24 weeks in target chronically infected HCV 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. Primary objective of the trial 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 600 mg BID in combinazione con Faldaprevir (BI 201335) 120 mg 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 un gruppo separato di pazienti con cirrosi compensata trattati per 24 settimane in aperto. 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
    To determine if a minimum historical target SVR12 rate of 71% can be achieved by the combination treatments of BI 207127, Faldaprevir and RBV, 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% puo' essere ottenuto 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 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 sub-GT1b confirmed by genotypic testing at screening, or HCV infection of sub-GT1a, GT1 with undefined subtype or 1a/1b subtype confirmed by genotypic testing at screening in patients with host IL-28b CC genotype. 3. Treatment naïve defined as: a. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and b. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection 4. Plasma HCV RNA ≥ 1,000 IU/mL at screening 5. Liver biopsy within three years or fibroscan within 6 months prior to randomisation. Note: patients with a liver biopsy performed 3 or more years or fibroscan performed 6 months or more prior to randomisation demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan. Patients with a liver biopsy performed 3 or more years (or fibroscan performed 6 months or more) prior to randomisation, negative for the presence of cirrhosis need to repeat the liver biopsy or fibroscan, with the result available before randomisation visit. 6. Age 18 – 75 years (inclusive) 7. Female patients a. with documented hysterectomy, or b. who have had both ovaries removed, or c. with documented tubal ligation, or 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 on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until 7 months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Accepted methods of contraception for females in this trial are diaphragm with spermicide substances, intrauterine devices, cervical caps 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 consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and c. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor). 8. 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 a: 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. Pazienti che non hanno mai ricevuto terapia con Interferone, Interferone Peghilato (PegIFN) e Ribavirina oppure PegIFN/RBV e che non hanno mai ricevuto una dose di un agente antivirale gia' approvato oppure ancora sperimentale per il trattamento di epatite C acuta o cronica; 4. HCV-RNA plasmatico &gt;= 1000 UI/ml allo screening; 5. Documentazione di biopsia epatica effettuata nei 3 anni o Fibroscan nei 6 mesi antecedenti la randomizzazione. Se la documentazione e' antecedente il test non deve essere ripetuto se documenta la cirrosi, mentre deve essere ripetuto in assenza di cirrosi ed il risultato del test deve essere disponibile prima della randomizzazione; 6. Eta' compresa tra i 18 e i 75 anni (inclusi);7. 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 (visita 2) che, se sessualmente attive, acconsentono 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 eta' 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); 8. 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 genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. HCV subtype 1a, GT1 undefined or 1a/1b in patients with IL28b non-CC polymorphism 3. Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson‟s disease. Note: patients with steatosis as part of the histologic findings on liver biopsy are not excluded. 4. HIV-1 or HIV-2 infection 5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag 6. Evidence of decompensated liver disease or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or any other evidence of previous decompensation 7. International Normalized Ratio (INR) of >=1.7 8. Serum albumin <=3.5 g/dL 9. Serum total bilirubin >2.0 times the upper limit of normal (ULN) with ratio of direct/indirect > 1. Patients with Gilbert's syndrome are not excluded. 10. Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 11. Patients with ongoing or historical photosensitivity or recurrent rash 12. History of alcohol or drug abuse (except cannabis) within the past 12 months 13. Body mass index <18 or > 35 kg/m2 14. Usage of any investigational drugs within 28 days prior to randomisation, or the planned usage of an investigational drug during the course of the current study 15. Known hypersensitivity to any ingredient of the study drugs 16. 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 17. Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and <= 100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation 18. A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina and arrhythmic disorders) current or within the previous 12 months before randomisation 19. Received concomitant hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to randomisation 20. Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 28 days prior to randomisation 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.The following exclusion criteria are potential contraindications for the use of PegIFN +/- RBV (for rationale please cf. Section 3.2) 21. Pre-existing psychiatric conditions including but not limited to severe depression or hospitalization for depression, suicidal ideation and attempted suicide, schizophrenia, bipolar illness, severe anxiety or personality disorder, a period of disability or impairment due to a psychiatric disease current or within the previous 3 years before randomisation 22. Abnormal thyroid function that cannot be controlled effectively by medication 23. Active autoimmune-mediated disease (e.g., Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis) 24. Requirement for chronic systemic corticosteroids (nasal or pulmonary steroids will be allowed); For the others criteria, please, referred to the protocol
    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, 1 non definito e 1 misto con polimorfismo IL28B CT o TT; 3. Evidenza di malattia epatica non imputabile all'infezione cronica da HCV, incluso ma non limitato a emocromatosi, malattia di Wilson o malattie epatiche autoimmuni, cirrosi biliare primaria; la steatosi diagnosticata durante la biopsia non rappresenta un criterio di esclusione; 4. Co-infezione da HIV-1 o HIV-2; 5. Infezione da epatite B (HBV) con HbsAg positivo; 6. 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; 7. Tempo di protrombina INR &gt;= 1.7; 8. Albumina serica &lt;= 3.5 g/dL; 9. Bilirubina totale &gt;2X ULN con rapporto diretta/indiretta &gt;1; i pazienti con la sindrome di Gilbert non sono esclusi; 10. 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 in situ della cervice opportunamente trattati ; 11. Episodi presenti o passati di fotosensitivita' oppure eruzioni cutanee ricorrenti; 12. Anamnesi di abuso etilico o abuso di droghe illecite (ad eccezione della cannabis) negli ultimi 12 mesi; 13. Body mass index &lt; 18 o &gt;35 kg/m2; 14. Utilizzo di farmaco sperimentale nei 28 giorni prima della randomizzazione o prevista somministrazione di farmaco sperimentale durante il periodo di partecipazione a questo studio; 15. Ipersensibilita' conosciuta a uno dei componenti dei farmaci dello studio; 16. 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; 17. 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; 18. Evidenza clinica di pregressa malattia cardiovascolare includendo una malattia cardiovascolare instabile o non controllata (per esempio angina instabile, infarto miocardico, cardiomiopatia, insufficienza cardiaca congestizia, aritmia significativa) attuale oppure nei 12 mesi precedenti la randomizzazione; 19. Utilizzo di fattori di crescita emopoietici o di immunomodulatori nei 28 giorni prima della randomizzazione; 20. 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; 21. Malattia psichiatrica preesistente inclusa ma non limitata a sindrome depressiva severa o ospedalizzazioni per depressione, idee omicide, tentativi di suicidio, schizofrenia, disordini bipolari, ansia severa, turbe della personalita' severe, mania, periodi di disabilita' o incapacita' dovuti ad un problema psichiatrico attuale o nei 3 anni antecedenti la randomizzazione; 22. Anormalità della funzionalità della tiroide che non può essere controllata efficacemente da un trattamento; 23. Presenza di una malattia auto-immune (ad es. malattia di Crohn, colite ulcerativa, porpora citopenica idiopatica, lupus eritematoso sistemico, anemia emolitica autoimmune, sclerodermia, psoriasi severa); 24. Assunzione cronica di corticosteroidi sistemici (sono permessi i trattamenti topici per via nasale o polmonare); Per gli altri criteri si faccia riferimento alla sinossi del protocollo in italiano
    E.5 End points
    E.5.1Primary end point(s)
    Sustained Virologic Response at Week 12 after end of active treatment (SVR12): Plasma HCV RNA level <25 IU/mL at 12 weeks after end of active* treatment.
    Il parametro primario e' la risposta virologica sostenuta dopo 12 settimane dall'interruzione del trattamento attivo, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 12 settimane dopo l'interruzione del trattamento attivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after end of active treatment
    12 settimane dopo l'interruzione del trattamento attivo
    E.5.2Secondary end point(s)
    -SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after end of active treatment. -SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after end of active treatment.
    -risposta virologica dopo 24 settimane dall'interruzione del trattamento attivo, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 24 settimane, dopo l'interruzione del trattamento attivo; -risposta virologica dopo 4 settimane dall'interruzione del trattamento attivo, considerata come il livello plasmatico di HCV RNA <25 IU/mL non rilevabile a 4 settimane, dopo l'interruzione del trattamento attivo;
    E.5.2.1Timepoint(s) of evaluation of this end point
    SVR 4:4 weeks after end of active treatment and SVR 24: 24 weeks after end of active 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 Yes
    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
    groups 1 and 2: double blind, placebo-controlled, group 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Canada
    Korea, Republic of
    Russian Federation
    Switzerland
    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
    LVLS
    LVLS
    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 months33
    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 months33
    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: 720
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 429
    F.4.2.2In the whole clinical trial 800
    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)
    No planned treatment or care after trial participation end.
    nessun trattamento o cura pianificato, alla fine della partecipazione alla sperimentazione
    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 Decision2013-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-11
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