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    Summary
    EudraCT Number:2011-005293-31
    Sponsor's Protocol Code Number:AI452-016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-09
    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 number2011-005293-31
    A.3Full title of the trial
    A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical
    Trial in which Peginterferon Lambda-1a (BMS-914143) was Administered
    for the Treatment of Chronic Hepatitis C
    Revised Protocol 01, incorporating Amendment 01 (version 3.0 dated 30-
    Jul-12)
    Studio di Follow-up a lungo termine su soggetti che hanno partecipato in uno studio clinico in cui è stato somministrato Peginterferon Lambda 1-a (BMS-914143) per il trattamento dell'Epatite Cronica C. Protocollo revisionato 01, che include l'emendamento al protocollo 01 (versione 3.0 del 30 luglio 2012).
    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
    Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial
    Studio di Follow-up a lungo termine su soggetti che hanno partecipato in uno studio clinico in cui è stato somministrato Peginterferon Lambda 1-a (BMS-914143) per il trattamento dell'Epatite Cronica C
    A.4.1Sponsor's protocol code numberAI452-016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01525810
    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.5.4Telephone number+
    B.5.5Fax number+
    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-914143
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.2
    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 nameNA
    D.3.2Product code BMS-914143
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis C
    Soggetti affetti da Epatite C Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C
    Soggetti affetti da 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 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 treated in a
    previous study with Lambda (BMS-91413) with or without ribavirin
    (RBV) and/or Direct Acting Antivirals (DAA), who have HCV RNA less
    than the limit of quantitation of the assay (< LOQ) at the completion of
    the required post-treatment follow-up in the previous (parent) study.
    Determinare la durata della risposta virologica nei soggetti trattati in un precedente studio con Peginterferon Lambda 1-a (BMS-914143) con o senza ribavirina (RBV) e / o agenti antivirali diretti (DAAs), che hanno HCV RNA inferiore al limite di quantificazione del saggio (&lt;LOQ) al completamento
    E.2.2Secondary objectives of the trial
    • To characterize the long-term progression of liver disease, as
    measured by laboratory indicators of hepatic status and function, allcause
    mortality, and liver-related mortality, among subjects previously
    treated with Lambda, with or without RBV and/or DAAs, who have HCV
    RNA < LOQ at the completion of the required post-treatment follow-up in
    the parent study;
    • To determine the duration of persistence of anti-Lambda antibodies in
    subjects who are positive for anti-Lambda antibodies at end of treatment
    (EOT) in the parent study.
    • Caratterizzare la progressione della malattia epatica a lungo termine, misurata con test di laboratorio sullo stato e sulla funzionalità epatica, la mortalità per tutte le cause e la mortalità correlata a patologie del fegato, nei soggetti trattati in precedenza con Lambda (BMS-914143) con o senza RBV e / o DAAs, che hanno HCV RNA &lt;LOQ al completamento del periodo di follow-up post-trattamento richiesto nello studio precedente

    • Determinare la durata della persistenza degli anticorpi anti-Lambda antibodies in soggetti che sono positivi per gli anticorpi anti-Lambda alla fine del trattamento (EOT) nello studio precedente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must have received Lambda in a previous trial and have HCV
    RNA <LOQ at the completion of the required post-treatment follow-up
    (must enter this study within 6 months of completion of the required
    posttreatment follow-up in the previous trial) NOTE: For blinded parent
    trials, subjects who have HCV RNA <LOQ at the completion of the
    required posttreatment follow-up may enter this study without
    knowledge of their treatment assignment in the parent study. Subjects
    who received control agents (eg, pegylated-interferon alfa) in the
    previous protocol will be allowed to participate until unblinded treatment
    information is released; at that time subjects will have the option to
    continue in the study.
    1) Consenso Informato Scritto
    a) Deve essere in grado di fornire il consenso informato e rispettare i requisiti dello studio a lungo termine.
    2) Popolazione Target
    a) Uomini e donne di 18 anni e oltre che devono avere ricevuto il farmaco lambda in un precedente studio (studio precedente), devono avere completato la partecipazione al precedente studio con Lambda e devono avere HCV RNA &lt; LOQ al completamento del follow-up di post-trattamento richiesto.
    b) Devono entrare in questo studio entro 6 mesi dal completamento del follow-up di post-trattamento richiesto nel precednete studio con Lambda
    E.4Principal exclusion criteria
    Subjects must not have been treated with any antiviral or
    immunomodulatory drug for hepatitis C after completion of treatment in
    the previous study of Peginterferon Lambda- 1a (BMS-914143)
    1) I soggetti non devono contemporaneamente partecipare a qualunque altro studio esclusi studi non-interventistici nel momento dell’arruolamento.
    2) I soggetti non devono essere stati trattati con farmaci antivirali o immuno-modulatori per Epatite C cronica (CHC) dopo il completamento del precedente studio con BMS-914143.
    3) Sono esclusi i detenuti o soggetti detenuti in modo coatto.
    4) Sono esclusi i soggetti detenuti obbligatoriamente per il trattamento di malattie psichiatriche o fisiche (ead es. Malattie infettive).
    E.5 End points
    E.5.1Primary end point(s)
    The durability of virologic response in subjects treated in a previous
    study with BMS-914143 who have HCV RNA less than the limit of
    quantitation of the assay (< LOQ) at the completion of the required posttreatment
    follow-up in the previous study.
    La durata della risposta virologica nei soggetti trattati nel precedente studio con BMS-914143 che hanno HCV RNA inferiore al limite di quantificazione del dosaggio (<LOQ) al termine del follow-up post-trattamento richiesto dallo studio precede
    E.5.1.1Timepoint(s) of evaluation of this end point
    Loss of virologic response assessed using HCV RNA at 24-week intervals.
    E.5.2Secondary end point(s)
    In subjects previously treated with BMS-914143 who have HCV RNA <
    LOQ at the completion of the required post-treatment follow-up in the
    parent study:
    - long-term progression of liver disease, all-cause mortality, and liverrelated
    mortality
    - duration of persistence of anti-Lambda antibodies in subjects who are
    positive for anti-Lambda antibodies at end of treatment in the parent
    study.
    Nei soggetti precedentemente trattati con BMS-914143 che hanno HCV RNA < LOQ al completamento del follow-up ldi post-trattamento richiesto dallo studio precedente:
    - A lungo termine, la progressione della malattia epatica, la mortalità per tutte le cause correlata alla malattia epatica
    - Durata della persistenza di anticorpi anti-Lambda anticorpi in soggetti che sono positivi agli anticorpi anti-Lambda alla fine del trattamento nello studio precedente
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Assessed at 24-week intervals
    - Assessed at 24-week intervals
    La perdita di risposta virologica valutata utilizzando HCV RNA 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
    Prospective, observational, long-term follow-up study of subjects who
    Prospective, observational, long-term follow-up study of subjects who
    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 Information not present in EudraCT
    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 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
    Australia
    Brazil
    Canada
    New Zealand
    Puerto Rico
    Turkey
    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 years6
    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: 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 2012-10-09. 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 state13
    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)
    Nessuno
    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 Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-20
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