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    Summary
    EudraCT Number:2011-005287-21
    Sponsor's Protocol Code Number:AI444-046
    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:2012-03-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005287-21
    A.3Full title of the trial
    A Long-Term Follow-up Study of Subjects Who Participated in A Clinical Trial in Which BMS-650032 and/or BMS-790052 Was Administered for the Treatment of Chronic Hepatitis C + Administrative Letter 01 (version 1.0 dated 14-Nov-11)Studio di Follow-up di tre anni per soggetti che hanno partecipato ad una precedente Sperimentazione Clinica con BMS-650032 e/o BMS-790052 per l’Epatire C Cronica
    Studio di Follow-up a lungo termine per soggetti che hanno partecipato ad una Sperimentazione Clinica in cui BMS-650032 e/o BMS-790052 sono stati somministrati per il trattamento dell’Epatite C Cronica + Administrative Letter 01 del 14-Nov-11
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Three-year Follow-up Study of Subjects Who Participated in a Previous BMS-650032 or BMS-790052 Chronic Hepatitis C Clinical Trial
    Studio di Follow-up di tre anni per soggetti che hanno partecipato ad una precedente Sperimentazione Clinica con BMS-650032 e/o BMS-790052 per l’Epatite C Cronica
    A.4.1Sponsor's protocol code numberAI444-046
    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 nameNA
    D.3.2Product code BMS-790052
    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.3.9.1CAS number NA
    D.3.9.2Current sponsor codeBMS-790052
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 nameNA
    D.3.2Product code BMS-650032
    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 INNasunaprevir
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeBMS-650032
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    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 14.1
    E.1.2Level LLT
    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 determine the durability of virologic response in subjects previously treated with BMS-650032 and/or BMS-790052 who achieved Sustained Virologic Response (SVR12) in the previous study.
    Determinare la durevolezza della risposta virologica insoggetti precedentemente trattati con BMS-650032 e/o BMS-790052 che hanno raggiunto la Risposta Virologica Sostenuta (SVR12) nel precedente studio
    E.2.2Secondary objectives of the trial
    • To assess the presence of HCV sequence variants over time in subjects previously treated with BMS-650032 and/or BMS-790052 who did not achieve SVR12 or relapsed after achieving SVR12 in the previous study. • To characterize the long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all-cause mortality, and liver-related mortality, among subjects previously treated with BMS-650032 and/or BMS-790052.
    Per valutare la presenza di varianti di sequenza dell’HCV nel tempo nei soggetti precedentemente trattati con BMS-650032 e / o BMS-790052, che non hanno raggiungto la SVR12 o hanno recidivato dopo aver ottenuto la SVR12 nello studio precedente. Per caratterizzare la progressione della malattia epatica a lungo termine, misurata dalla frequenza della progressione della malattia epatica, tutte le cause di mortalità e la mortalità correlata al fegato, tra i soggetti precedentemente trattati con BMS-650032 e / o BMS-790052.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    completed participation in a previous study of BMS-650032 and/or BMS- 790052 (NOTE: Subjects who received control agents [eg, placebo] in the previous study will be allowed to participate until unblinded data are released) - Enrolled within 6 months of completing previous study or within 6 months of protocol availability
    Aver ricevuto almeno una dose di BMS-650032 e/o BMS-790052 ed aver completato la partecipazione ad un precedente studio di BMS-650032 e/o BMS- 790052 (NOTA: I soggetti che hanno ricevuto agenti di controllo (ad esempio, placebo) nel precedente studio potranno partecipare in questo studio fino a quando i dati in aperto saranno rilasciati. Arruolamento entro 6 mesi dalla conclusione del precedente studio o entro 6 mesi dalla disponibilità del protocollo
    E.4Principal exclusion criteria
    Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study
    Il trattamento con qualsiasi farmaco antivirale o immunomodulatore per l'epatite C dopo il completamento dello studio precedente
    E.5 End points
    E.5.1Primary end point(s)
    The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with BMS-650032 and/or BMS-790052.
    La durata della risposta virologica, come valutata dal tempo di perdita della risposta virologica sostenuta dopo aver ottenuto la risposta virale (SVR12) in un precedente studio con BMS-650032 e / o di BMS-790052
    E.5.1.1Timepoint(s) of evaluation of this end point
    Loss of virologic response assessed using HCV RNA at 24-week intervals
    Perdita della risposta virologica valutata utilizzando l’ RNA HCV a 24 settimane di intervallo
    E.5.2Secondary end point(s)
    In subjects previously treated with BMS-650032 and/or BMS-790052: - Frequency of viral genotypic substitutions in those who did not achieve or did not maintain SVR12 - Frequency of hepatic disease progression, all-cause mortality, liverrelated mortality
    Nei soggetti precedentemente trattati con BMS-650032 e / o di BMS-790052: - Frequenza di sostituzioni genotipiche virali in coloro che non hanno raggiunto o non hanno mantenuto la SVR12 - Frequenza di progressione della malattia epatica, mortalità per qualsiasi causa e mortalità legata al fegato
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Assessed using resistance testing samples at 24-week intervals - Assessed at 24-week intervals
    - Valutate usando campioni di test di resistenza a 24 settimane di intervallo. - Valutate a 24 settimane di intervallo
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Studio prosp,osservaz,f-u lungo term di sogg partecip studi con BMS-650032 e/o BMS-790052
    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 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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Japan
    Mexico
    New Zealand
    Puerto Rico
    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 years0
    E.8.9.1In the Member State concerned months64
    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 months64
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 960
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2012-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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