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    Summary
    EudraCT Number:2014-003898-42
    Sponsor's Protocol Code Number:GS-US-342-1446
    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:2015-05-14
    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 number2014-003898-42
    A.3Full title of the trial
    An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection
    Studio in aperto sulla combinazione Sofosbuvir/GS-5816 a dose fissa in soggetti con infezione cronica da HCV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at the treatment of SOF/GS-5816 in patients with hepatitis C infection
    Uno studio che valuta il trattamento di SOF/GS-5816 in pazienti con infezione da epatite C
    A.3.2Name or abbreviated title of the trial where available
    An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infect
    Uno studio che valuta il trattamento di SOF/GS-5816 in pazienti con infezione da epatite C
    A.4.1Sponsor's protocol code numberGS-US-342-1446
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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.3.2Product code SOF/GS-5816
    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 INNSOFOSBUVIR
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeGS-7977
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-5816
    D.3.9.2Current sponsor codeGS-5816
    D.3.9.3Other descriptive nameGS-5816
    D.3.9.4EV Substance CodeSUB117293
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.3.11.13.1Other medicinal product typeNA
    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 C Virus Infection
    Infezione Cronica da Virus Epatite C
    E.1.1.1Medical condition in easily understood language
    Hepatitis C
    Epatite C
    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 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    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 evaluate the efficacy of treatment with SOF/GS-5816 for 12 weeks in subjects with chronic HCV infection as measured by the proportion of subjects with SVR12

    - To evaluate the safety and tolerability of treatment with SOF/GS-5816 for 12 weeks
    Valutare l’efficacia del trattamento di SOF/GS-5816 per 12 settimane in soggetti con infezione cronica da HCV in base alla percentuale di soggetti con risposta virale sostenuta a 12 settimane (sustained viral response 12 weeks, SVR12)
    - Valutare la sicurezza e la tollerabilità del trattamento con SOF/GS-5816 per 12 settimane
    E.2.2Secondary objectives of the trial
    - To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)

    - To evaluate the proportion of subjects with virologic failure

    - To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment

    - To evaluate the emergence of viral resistance to SOF and GS 5816 during treatment and after cessation of treatment
    Determinare la percentuale di soggetti con SVR a 4 e a 24 settimane dopo la cessazione del trattamento (SVR4 e SVR24)
    - Valutare la percentuale di soggetti con mancata risposta virologica
    - Valutare la cinetica dell’RNA HCV circolante durante il trattamento e dopo la cessazione del trattamento
    - Valutare l’insorgenza della resistenza virale a SOF e GS-5816 durante il trattamento e dopo la cessazione del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent
    2) Chronic HCV (≥ 6 months) documented by prior medical history or biopsy
    3) Subject was administered SOF/GS-5816 placebo Gilead study GS-US-342-1138
    - The subject must have completed protocol mandated treatment and post-treatment assessments.
    4) HCV RNA > LLOQ
    5) Cirrhosis Determination
    a. Cirrhosis is defined as any one of the following
    i) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥5)
    ii) FibroTest® score > 0.75 AND an AST:platelet ratio index (APRI) > 2 during Screening
    iii) Fibroscan with a result of >12.5 kPa
    b. Absence of cirrhosis is defined as any one of the following:
    i) Liver biopsy within 2 years of Screening in the GS-US-342-1138 study showing absence of cirrhosis
    ii) FibroTest® score ≤ 0.48 AND APRI ≤ 1 performed during Screening
    iii) Fibroscan with a result of ≤ 12.5 kPa within ≤ 6 months of Baseline/Day 1 in the GS-US-342-1138 study
    In the absence of a definitive diagnosis of presence or absence of cirrhosis by Fibrotest® /APRI using the above criteria, a liver biopsy or fibroscan is required. Liver biopsy results will supersede Fibrotest® /APRI or fibroscan results and be considered definitive.
    6) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
    7) Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Baseline/Day 1 prior to randomization.
    8) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    9) Lactating females must agree to discontinue nursing before the study drug is administered
    10) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
    11) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
    ) Disponibilità e capacità a fornire un consenso informato scritto
    2) Infezione cronica da HCV (≥ 6 mesi) documentata da una precedente storia medica o biopsia
    3) Soggetto a cui è stato somministrato SOF/GS-5816 placebo nello studio Gilead GS-US-342-1138
    - Il soggetto deve aver completato il trattamento e le valutazioni post-trattamento del protocollo.
    4) HCV RNA > LLOQ
    5) Determinazione di cirrosi
    a) La cirrosi è definita come uno qualsiasi dei seguenti
    i) Biopsia epatica che mostra cirrosi (ad esempio, il punteggio Metavir = 4 o punteggio Ishak ≥5)
    ii) Punteggio FibroTest®> 0.75 E AST: indice del rapporto piastrine (APRI)> 2 durante lo Screening
    iii) Fibroscan® con un risultato di> 12,5 kPa
    b. Assenza di cirrosi definita come uno qualsiasi dei seguenti:
    i) Biopsia epatica entro 2 anni dallo Screening nello studio GS-US-342-1138 che mostra assenza di cirrosi
    ii) FibroTest® punteggio ≤ 0.48 E APRI ≤ 1 eseguita durante lo Screening
    iii) Fibroscan® con un risultato di 12,5 kPa ≤ entro ≤ 6 mesi dal Baseline/giorno 1 nello studio GS-US-342-1138 in assenza di una diagnosi definitiva di presenza o assenza di cirrosi da Fibrotest® / APRI utilizzando i criteri di cui sopra, una biopsia epatica o è necessario fibroscan. I risultati della biopsia epatica sostituiranno i risultati di Fibrotest® / APRI o fibroScan e saranno considerati definitivi.
    6) L'immagine del fegato entro 6 mesi dal Baseline / Day 1 è necessaria per i pazienti cirrotici solo per escludere il carcinoma epatocellulare (HCC)
    7) Le donne in età fertile (come definito nell'Appendice 4) devono avere un test di gravidanza sul siero negativo allo screening e un test di gravidenza sulle urine negativo al Baseline / giorno 1 prima della randomizzazione.
    8) Le donne e gli uomini con partner in età fertile che hanno rapporti eterosessuali devono acconsentire di usare i/il medoto/i contraccettivi specificati nel protocollo
    9) Le donne che allattano devono accettare di interrompere l'allattamento prima che il farmaco dello studio venga somministrato
    10) Il soggetto deve essere di buona salute generale, con l'eccezione di infezione cronica da HCV, come determinato dallo Sperimentatore.
    11) Il soggetto deve essere in grado di attenersi alle istruzioni per il dosaggio e la somministrazione del farmaco in studio ed essere in grado di completare le valutazioni programmate dello studio.
    E.4Principal exclusion criteria
    1) Current or prior history of any of the following:
    a. Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
    b. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
    c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
    d. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
    e. Solid organ transplantation.
    f. Significant pulmonary disease, significant cardiac disease or porphyria.
    g. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last 12 months may be included.
    h. Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
    i) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
    2) Screening ECG with clinically significant abnormalities
    3) Subjects with the following laboratory results at screening are excluded unless enrollment is approved by the sponsor medical monitor:
    a) ALT > 10 x the upper limit of normal (ULN)
    b) AST > 10 x ULN
    c) Direct bilirubin > 1.5 x ULN
    d) Platelets < 50,000/microlitre
    e) HbA1c > 8.5%
    f) Creatinine clearance (CLcr) < 60 mL /min as calculated by the Cockcroft-Gault equation
    g) Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
    h) Albumin < 3 g/dL
    i) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    4) Pregnant or nursing female or male with pregnant female partner.
    5) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis).
    6) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
    7) Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator.
    8) Use of any prohibited concomitant medications
    9) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
    10) Known hypersensitivity to GS-5816, SOF, or formulation excipients.
    11) History of clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia)
    1) Anamnesi concomitante o antecedente di una delle seguenti condizioni:
    a. Patologia clinicamente significativa (differente dall'HCV) oppure ogni altra condizione clinica che possa interferire con il trattamento, Ia valutazione o l'aderenza al protocollo; i soggetti attualmente in fase di valutazione per una malattia potenzialmente clinicamente significativa (differente dall'HCV) sono anche esclusi.
    b) Disordini gastrointestinali o condizioni post operatorie che possano interferire con l'assorbimento dei farmaci in studio.
    c) difficoltà nel prelievo di sangue e/o difficile accesso venoso per fini di flebotomia.
    d) Decompensazione epatica clinica (per es. ascite, encefalopatia o emorragia di varici).
    e) trapianto d'organo solido.
    f) Malattia cardiaca o polmonare significativa.
    g) Ospedalizzazione psichiatrica, tentativo di suicidio, e/o periodo di disabilità a seguito di patologia psichiatrica negli ultimi 5 anni. Possono essere inclusi soggetti con malattia psichiatrica (senza le condizioni precedenti) tenuta sotto controllo con regime di trattamento permanente per almeno 12 mesi prima della randomizzazione o i soggetti che non hanno necessitato di
    trattamento negli ultimi 12 mesi.
    h) Neoplasie maligne entro i cinque anni precedenti lo screening, con l'eccezione di tumori specifici che sono stati curati con resezione chirurgica (carcinoma a cellule basali, ecc). Soggetti sottoposti a valutazione di neoplasie maligne non sono eleggibili.
    i) Allergie significative a farmaci (come anafilassi o epatotossicita).
    2) ECG allo screening con anomalie clinicamente significative
    3) Soggetti con i seguenti valori di laboratorio allo screening sono esclusi a meno che l'arruolamento è approvato dal medical monitor dello sponsor:
    a) ALT > 10 volte il limite superiore (ULN)
    b) AST > 10 x ULN
    c) Bilirubina diretta > 1.5 x ULN
    d) piastrine < 50,000/microlitro
    e) HbA1c > 8.5%
    f) Clearance della creatinina (CLcr) < 60 ml /min calcolato in base all'equazione Cockcroft-Gault
    g) Emoglobina < 11 g/dl per soggetti femminili; < 12 g/dL per soggetti maschili
    h) Albumina < 3 g/dL
    i) INR > 1.5 x ULN ad eccezione di soggetti con emofilia nota o in regime costante di anticoagulanti che puo alterare il valore di INR
    4) Donna incinta o durante l'allattamento o uomo che ha una moglie/compagna incinta.
    5) Malattia epatica cronica di eziologia non-HCV (ad esempio, emocromatosi, malattia di Wilson, deficit di alfa-1 antitripsina, colangite).
    6) Infezione da HBV o da HIV.
    7) Casi clinici rilevanti di abuso di alcol o droga entro i 12 mesi dallo screening. Uno screening positivo alla droga escluderà i soggetti a meno che non può essere spiegato da un farmaco prescritto; la diagnosi e la prescrizione devono essere approvate dallo sperimentatore.
    8) Uso in concomitanza di farmaci proibiti
    9) Uso continuativo di farmaci immunosoppressori somministrati per via sistemica (ad esempio prednisone equivalente > 10 mg die).
    10) Nota ipersensibilità a GS-5816, SOF, o eccipienti della formulazione.
    11) Anamnesi di emoglobinopatia di rilevanza clinica (ad esempio anemia falciforme, talassemia)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after cessation of therapy) in the Full Analysis Set (FAS) population.

    The primary safety endpoint is any AE leading to permanent discontinuation of study drug.
    Lìend point primario di efficacia è Ia SVR12 (HCV RNA <LLOQ 12 settimane dopo Ia fine della terapia) nella popolazione del Full Analysis Set (FAS). L'end point primario di sicurezza è ogni evento avverso che conduca alia terminazione permanente dell'assunzione del farmaco sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The safety and tolerability endpoints are evaluated during the course of treatment. The efficacy endpoint is evaluated 12 weeks after discontinuation of therapy.
    Gli end point di sicurezza e tollerabilità sono valutati durante Ia durata dello trattamento. L'end point di efficacia è valutato nelle 12 settimane dopo l'ultima dose di trattamento.
    E.5.2Secondary end point(s)
    - The proportion of subjects with: HCV RNA < LLOQ at 4 and 24 weeks after cessation of therapy (SVR4 and SVR24)
    - The proportion of subjects with HCV RNA < LLOQ on treatment
    - HCV RNA change from Baseline/Day 1
    - The proportion of subjects with virologic failure
    Proporzione di soggetti con: HCV RNA < LLOQ a 4 e 24 settimane dal termine della terapia (SVR4 e SVR24) - Proporzione di soggetti con HCV RNA < LLOQ durante il trattamento - Variazioni al HCV RNA dalla visita basale/giorno 1 - Proporzione di soggetti con fallimento virologico
    E.5.2.1Timepoint(s) of evaluation of this end point
    The efficacy endpoints are evaluated 4 and 24 weeks after discontinuation of therapy.

    The other endpoints are evaluated during the course of treatment.
    Gli end point secondari di efficacia verranno valutati a 4 e 24 settimane dopo il trattamento. Gli altri end point verranno valutati nel corso del trattamento.
    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 No
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Belgium
    Canada
    France
    Germany
    Hong Kong
    Italy
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 100
    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)
    Subjects who do not achieve SVR will be eligible for enrollment in an observational Sequence Registry Study.
    I soggetti che non ottengono una RVS potranno essere arruolati in uno studio osservazionale di registro per le sequenze.
    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 Decision2015-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
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