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    Summary
    EudraCT Number:2015-001050-16
    Sponsor's Protocol Code Number:GS-US-330-1508
    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:2018-02-27
    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 number2015-001050-16
    A.3Full title of the trial
    A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection.
    Studio di registro di follow-up a lungo termine di soggetti trattati in una sperimentazione sponsorizzata da Gilead su soggetti affetti da infezione cronica da virus dell’epatite B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to follow patients who took part in a Gilead study for Hepatitis B for 3 years after they finish the original trial.
    Studio per seguire i pazienti che hanno preso parte a uno studio Gilead per l'epatite B per 3 anni dopo hanno concluso lo studio originale.
    A.3.2Name or abbreviated title of the trial where available
    A study to follow patients who took part in a Gilead study for Hepatitis B for 3 years after they fi
    Studio per seguire i pazienti che hanno preso parte a uno studio Gilead per l'epatite B per 3 anni d
    A.4.1Sponsor's protocol code numberGS-US-330-1508
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02258581
    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 INCORPORATED
    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 Trial Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0
    B.5.5Fax number00441223897284
    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 Yes
    D.2.1.1.1Trade name VIREAD
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCE INTERNATIONAL LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameViread
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATO
    D.3.9.1CAS number 202138-50-9
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive nameTENOFOVIR DISOPROXIL FUMARATO
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 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 nameGS-4774
    D.3.2Product code GS-4774
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1518923-92-6
    D.3.9.2Current sponsor codeGS-4774
    D.3.9.3Other descriptive nameGS-4774
    D.3.9.4EV Substance CodeSUB166605
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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: 4
    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 nameGS-9620
    D.3.2Product code GS-9620
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1228585-88-3
    D.3.9.2Current sponsor codeGS-9620
    D.3.9.3Other descriptive nameGS-9620
    D.3.9.4EV Substance CodeSUB166250
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1228585-88-3
    D.3.9.2Current sponsor codeGS-9620
    D.3.9.3Other descriptive nameGS-9620
    D.3.9.4EV Substance CodeSUB166250
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1228585-88-3
    D.3.9.2Current sponsor codeGS-9620
    D.3.9.3Other descriptive nameGS-9620
    D.3.9.4EV Substance CodeSUB166250
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis B virus infection
    Infezione da virus dell'epatite B cronica
    E.1.1.1Medical condition in easily understood language
    Hepatitis B
    Epatite B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019731
    E.1.2Term Hepatitis B
    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
    The primary objective of this study is:
    - To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144
    L'obiettivo primario di questo studio è:
    - Valutare gli effetti a lungo termine del trattamento del virus dell’epatite B (Hepatitis B Virus, HBV) dello studio di base sui mutamenti sierologici dell’HBV fino alla Settimana 144
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is:
    - To evaluate the long term effects of HBV treatment of the parental study on changes in HBV DNA levels through Week 144
    L'obiettivo secondario di questo studio è:
    - Valutare gli effetti a lungo termine del trattamento dell’HBV dello studio di base sui mutamenti nei livelli di DNA dell’HBV fino alla Settimana 144
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
    1. Must have participated in a Gilead-sponsored CHB study no more than 120 days prior to Baseline (Day 1), except for subjects from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol
    2. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    3. Must be willing and able to comply with the visit schedule and study requirements

    For subjects from previous Gilead-sponsored study number GS-US-174-0149, subjects must meet either one of the following inclusion criteria to be eligible to participate in the study:
    4. Must have documented HBV DNA < 2,000 IU/mL at time of Screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
    5. Must have documented HBsAg negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment
    Per essere idonei a partecipare allo studio, i soggetti devono soddisfare tutti i seguenti criteri di inclusione.
    1.Avere partecipato a uno studio della CHB sponsorizzato da Gilead non più di 120 giorni prima del Basale (Giorno 1), fatta eccezione per i soggetti provenienti dal precedente studio numero GS-US-174-0149 sponsorizzato da Gilead, che avranno fino a un anno dalla loro ultima visita in quel protocollo
    2. Essere in grado di comprendere e firmare un modulo di consenso informato scritto, che deve essere consegnato prima dell’inizio delle procedure di studio.
    3. Avere volontà e capacità di attenersi al programma di visite e ai requisiti dello studio.

    I soggetti provenienti dal precedente studio numero GS US-174-0149 sponsorizzato da Gilead devono soddisfare uno dei seguenti criteri di inclusione per essere ritenuti idonei a partecipare allo studio:
    4. Avere un DNA dell’HBV < 2.000 UI/ml documentato al momento della visita di Screening, che dovrà avvenire entro il 1° anno successivo all’ultima visita dello studio GS-US-174-0149
    5. Avere uno stato dell’HBsAg negativo documentato in qualsiasi momento durante la partecipazione allo studio GS-US-174-0149 indipendentemente dal trattamento dell’HBV in corso
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
    1. Patient participating or planning to participate in another clinical study with an investigational agent
    2. History or current presence ofclinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol
    3. Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed

    For subjects from previous Gilead-sponsored study number GS-US-174-0149 meeting Inclusion Criteria #4, subjects who meet the following exclusion criteria are not eligible to participate in the study:
    4. Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149
    I soggetti che rispondono a uno qualsiasi dei seguenti criteri di esclusione non sono idonei a partecipare allo studio.
    1. Partecipazione o previsione di partecipare a un altro studio clinico con un agente sperimentale
    2. Pregressa o attuale presenza di una malattia clinicamente significativa o di altro disturbo clinico maggiore che possa interferire con il follow-up del soggetto, le valutazioni o la conformità al protocollo.
    3. Ritenuto, dallo Sperimentatore dello studio, inadatto per la partecipazione allo studio per qualsiasi motivo non altrimenti elencato

    Per i soggetti provenienti dal precedente studio numero GS US-174-0149 sponsorizzato da Gilead che soddisfano il criterio di inclusione n. 4, i soggetti che soddisfano i seguenti criteri di esclusione non sono idonei a partecipare allo studio:
    4.Avere ricevuto il trattamento con tenofovir disoproxil fumarato (TDF) in monoterapia come parte del Braccio C dello studio GS US-174-0149 (Braccio TDF in monoterapia) o del ritrattamento con TDF e avere assunto qualsiasi terapia antivirale per l’HBV a partire dal completamento dello studio GS-US-174-0149
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this Registry are:
    For subjects who are HBsAg positive at Baseline:
    -- The proportion of subjects with serum HBsAg decline ≥ 0.5 log10
    IU/ml from Baseline at Week 48
    For subjects who are HBsAg negative at Baseline:
    -- The proportion of subjects who remain HBsAg negative at Week 48
    Gli endpoint primari di questo Registro sono:

    Per i soggetti che sono HBsAg positivi al basale:
    - La percentuale di soggetti con siero HBsAg declino ≥ 0,5 log10
    IU / ml dal basale alla settimana 48
    Per i soggetti che sono HBsAg negativi al basale:
    - La percentuale di soggetti che rimangono HBsAg negativo alla settimana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Settimana 48
    E.5.2Secondary end point(s)
    The secondary endpoints of this Registry are:
    For subjects who are HBsAg positive at Baseline:
    --The proportion of subjects with serum HBsAg decline ≥ 0.5 log10 IU/ml from Baseline at Week 144
    --The proportion of subjects who achieve HBsAg loss at Weeks 48 and 144
    For subjects who are HBsAg negative at Baseline:
    --The proportion of subjects who remain HBsAg negative at Week 144
    For subjects HBeAg positive at Baseline:
    -- The proportion of subjects with HBeAg loss and seroconversion at Week 48
    -- The proportion of subjects with HBeAg loss and seroconversion at Week 144
    For HBeAg positive subjects who achieved HBeAg seroconversion during
    the parental study:
    -- The proportion of subjects who remain HBeAg negative and HBeAb positive at Week 48
    -- The proportion of subjects who remain HBeAg negative and HBeAb positive at Week 144.
    For subjects on treatment with OAV anti-HBV, the proportion of subjects with HBV-DNA < LLOQ at Weeks 48, 96 and 144
    -- The change from Baseline in HBV DNA at Weeks 48, 96, and 144
    Gli endpoints secondari di questo Registro sono:
    Per i soggetti che sono HBsAg positivi al basale:
    --La proporzione di soggetti con siero HBsAg declino ≥ 0,5 log10 IU / ml rispetto al basale alla settimana 144
    ---La proporzione di soggetti che raggiunge la perdita di HBsAg alle settimane 48 e 144
    Per i soggetti che sono HBsAg negativi al basale:
    --La proporzione di soggetti che rimangono HBsAg negativo alla settimana 144
    Per i soggetti HBeAg positivi al basale:
    - La percentuale di soggetti con perdita di HBeAg e sieroconversione alla settimana 48
    - La percentuale di soggetti con perdita di HBeAg e sieroconversione alla settimana 144
    Per i soggetti HBeAg positivi che hanno raggiunto la sieroconversione HBeAg durante lo studio di base:
    - La percentuale di soggetti che rimangono HBeAg negativa e HBeAg positivo alla settimana 48
    - La percentuale di soggetti che rimangono HBeAg negativa e HBeAg positivo alla settimana 144
    Per i soggetti in trattamento con anti-HBV OAV, la percentuale di soggetti con HBV-DNA <LLOQ alle settimane 48, 96 e 144
    - Il cambiamento dal basale dell'HBV DNA a 48 settimane, 96, e 144
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 48, 96 and 144
    Settimane 48, 96 e 144
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Long-term follow-up.
    Follow up a lungo termine
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Questo è uno studio di Registro di follow up a lungo termine
    This is a long-term follow-up Registry study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    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
    Hong Kong
    India
    Italy
    Korea, Republic of
    Netherlands
    Romania
    Taiwan
    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 years6
    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 years7
    E.8.9.2In all countries concerned by the trial months0
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.4Nursing women Yes
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 500
    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)
    Once they have completed participation in this Registry study, subjects will return to the standard of care by their physician.
    Una volta che hanno completato partecipazione a questo studio d i Registro, i soggetti torneranno al trattamento standard con il loro medico.
    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 Decision2016-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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