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    Summary
    EudraCT Number:2011-004885-14
    Sponsor's Protocol Code Number:AI452-017
    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:2012-08-29
    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 number2011-004885-14
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the
    Efficacy and Safety of Peginterferon Lambda-1a, with and without
    Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with
    Ribavirin, in the Treatment of Naìve Genotype 2 and 3 Chronic Hepatitis C
    Subjects
    Studio di fase III, Randomizzato, in doppio cieco, controllato di valutazione dell'efficacia e sicurezza di Peginterferone Lambda-1a, con e senza Daclatasvir, a confronto con Peginterferone alfa-2a ognuno in combinazione con Ribavirina, in soggetti affetti da Epatite-C Cronica Genotipo 2 e 3 naìve al trattamento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Pegylated Interferon Lambda with and without
    Daclatasvir, compared to Pegylated Interferon Alfa, plus Ribavirin in
    Subjects with Hepatitis C Genotype 2 and 3
    Studio sulla Sicurezza ed Efficacia di Interferone Lambda Peghilato, con e senza Daclatasvir, a confronto con Interferone Alfa Peghilato, piu' Ribavirina in soggetti con Epatite-C genotipo 2 e 3.
    A.4.1Sponsor's protocol code numberAI452-017
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 namePegylated Interferon Lambda
    D.3.2Product code BMS-914143 / PEG-rIL-29 / PEG IFN-λ1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON LAMBDA-1a
    D.3.9.1CAS number 914617-98-4
    D.3.9.2Current sponsor codeBMS-914143 / PEG IFN-λ1
    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 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 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: 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 nameDaclatasvir
    D.3.2Product code BMS-790052/DCV
    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 INNdaclatasvir
    D.3.9.2Current sponsor codeBMS-790052
    D.3.9.3Other descriptive nameHCV NS5A Replication Co-Factor Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 RoleComparator
    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 Ribasphere
    D.2.1.1.2Name of the Marketing Authorisation holderThree Rivers Pharmaceuticals, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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 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 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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis C
    Epatite C Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C
    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 15.0
    E.1.2Level HLT
    E.1.2Classification code 10057212
    E.1.2Term Hepatitis viral infections
    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 is to evaluate, in treatment-naive subjects with
    chronic HCV GT-2 or -3 infection:
    • SVR12 following 24 weeks of treatment with Lambda/RBV and the
    SVR12 following 24 weeks of treatment with alfa-2a/RBV
    • SVR12 following 12 weeks of treatment with Lambda/RBV/DCV and
    the SVR12 following 24 weeks of treatment with alfa-2a/RBV
    L’obiettivo primario di questo studio è valutare nei soggetti naïve al trattamento affetti da epatite C cronica con genotipo 2 o 3:
    • La SVR12 a seguito di 24 settimane di trattamento con Lambda/RBV e la SVR12 a seguito di 24 settimane di trattamento con alfa-2a/RBV
    • La SVR12 a seguito di 12 settimane di trattamento con Lambda/RBV/DCV e la SVR12 a seguito di 24 settimane di trattamento con alfa-2a/RBV
    E.2.2Secondary objectives of the trial
    • Evaluate the safety of 24 weeks of treatment with Lambda/RBV and 12
    weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of
    treatment with alfa-2a/RBV in reducing treatment emergent cytopenic
    abnormalities
    • Evaluate the following on-treatment IFN-associated symptoms
    following 24 weeks of treatment with Lambda/RBV and 12 weeks of
    treatment with Lambda/RBV/DCV compared to 24 weeks of treatment
    with alfa-2a/RBV:
    − Flu-like symptoms
    − Musculoskeletal symptoms
    • Evaluate SVR24 by treatment group
    • Evaluate, by treatment group, safety as measured by the frequency of
    dose reductions, discontinuations due to adverse events (AEs), and
    serious adverse events (SAEs)
    • Evaluate SVR12, by treatment group, in subjects with GT-3 chronic
    HCV infection
    • Evaluate on-treatment IFN-associated constitutional symptoms
    valutare:
    •la risp virologica rapid (RVR) per gruppo di trattam
    •la sicurezza di 24 sett di trattam con Lambda/RBV e 12 settimane di trattam con Lambda/RBV/DCV a confronto con 24 settimane di trattamento con alfa-2a/RBV nel ridurre le anomalie citopeniche causate dal trattamento
    •i seguenti sintomi associati agli interferoni durante il trattam,dopo 24 settimane di trattamento con Lambda/RBV e 12 settimane di trattam con Lambda/RBV/DCV a confronto con 24 settimane di trattam con alfa-2a/RBV: sintomi simil-influenzali, sintomi muscoloscheletrici
    •la SVR24 per gruppo di trattam
    •la sicurezza, per gruppo di trattamento, misurata come la frequenza di riduzioni di dose, discontinuazioni dovute ad eventi avversi, ed eventi avversi seri (SAE)
    •la SVR12 per gruppo di trattam, in sogg GT-3 con infezione cronica da HCV
    •sintomi costituzionali durante il trattamento associati agli interfero
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Chronic hepatitis C, Genotype 2 or 3
    • Naïve to prior anti-HCV therapy
    •Epatite C Cronica, genotipo 2 o 3
    •Naive a precedenti terapie anti-HCV
    E.4Principal exclusion criteria
    • Infected with HCV other than Genotype 2 or 3
    • Positive HBsAg, or HIV-1/HIV-2 antibody
    • Evidence of liver disease other than HCV
    • Active substance abuse
    • Evidence of decompensated cirrhosis
    •Infezione da HCV di genotipo diverso dal 2 o 3
    •Positività per HbsAg, o anticorpi HIV-1/HIV-2
    •Evidenza di malattia epatica diversa dall’HCV
    •Uso attivo di sostanze da abuso
    •Evidenza di cirrosi decompensata
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of chronically infected
    genotype 2 and 3 subjects who achieve SVR12.
    L’endpoint primario di efficacia è la proporzione di soggetti con infezione cronica da HCV genotipo 2 e 3 che ottengono la SVR12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-treatment week 12
    Settimana 12 post-trattamento
    E.5.2Secondary end point(s)
    • Proportion of subjects with RVR
    • Proportion of subjects with treatment emergent cytopenic
    abnormalities
    • Proportion of subjects with on-treatment interferon-associated flu-like
    symptoms
    • Proportion of subjects with on-treatment musculoskeletal symptoms
    • Proportion of subjects with SVR24 by treatment group
    • Proportion of subjects with on-treatment SAEs
    • Proportion of subjects with dose reductions
    • Proportion of subjects who discontinue due to AEs
    • Proportion of subjects with SVR12 in subjects with GT-3 chronic HCV
    infection
    • Proportion of subjects with on-treatment constitutional symptoms
    • Proporzione di soggetti con RVR
    • Proporzione di soggetti con anomalie citopeniche dovute al trattamento
    • Proporzione di soggetti con sindrome simil-influenzale associata all’interferone durante il trattamento
    • Proporzione di soggetti con sintomi muscoloscheletrici durante il trattamento
    • Proporzione di soggetti con SVR per gruppo di trattamento
    • Proporzione di soggetti con SAE durante il trattamento
    • Proporzione di soggetti con riduzioni di dose
    • Proporzione di soggetti che discontinuano a causa di eventi avversi
    • Proporzione di soggetti con SVR12 in soggetti con infezione cronica da HCV GT3
    • Proporzione di soggetti con sintomi copstituzionali durante il trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Day 1 through 24 weeks post end treatment
    Dal Giorno 1 fino a 24 settimane post-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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Outcomes Research Assessments, Resistance and Immunogenicity
    Outcomes Research Assessments, Resistance and Immunogenicity
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Hong Kong
    India
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Singapore
    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
    The end of the study is defined as LPLV. The last visit is defined as the
    last post-treatment follow-up subject visit.
    After the treatment and follow-up period, subjects treated with Lambda
    may be asked to enroll in a separate follow-up observational study to
    assess long-term virologic response and HCV-related complications.
    Definita come LPLV. L’ultima visita è defcome l’ultima visita del FU post trattam. Successiv al periodo di trattam e di FU, i sogg tratt con Lambda potrebbero ess invitati a partecip in uno studio osservaz di FU separato
    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 months26
    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 months26
    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: 1125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 351
    F.4.2.2In the whole clinical trial 1250
    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)
    At the end of the study, BMS will not continue to supply study drug to
    subjects/investigators unless BMS chooses to extend the study. The
    investigator should ensure that the subject receives appropriate
    standard of care to treat the condition under study.
    Alla fine dello studio, BMS non continuerà a fornire farmaco in studio ai soggetti/sperimentatori, a meno che BMS decida di estendere lo studio. Lo sperimentatore dovrebbe assicurare che i soggetti ricevano l’appropriato standard of care per trattare la condizione in studio
    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 Decision2012-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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