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    Summary
    EudraCT Number:2016-004967-38
    Sponsor's Protocol Code Number:M16-135
    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:2021-06-08
    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 number2016-004967-38
    A.3Full title of the trial
    A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Na¿ve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
    Sperimentazione Multicentrica in Aperto a Braccio Singolo per Valutare l¿Efficacia e la Sicurezza di Glecaprevir (GLE) / Pibrentasvir (PIB) in Soggetti Adulti Affetti da Infezione Cronica da Virus dell¿Epatite C (HCV) di Genotipo 1, 2, 4, 5 o 6 con Cirrosi Compensata e Na¿ve Rispetto al Trattamento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Na¿ve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
    Sperimentazione Multicentrica in Aperto a Braccio Singolo per Valutare l¿Efficacia e la Sicurezza di Glecaprevir (GLE) / Pibrentasvir (PIB) in Soggetti Adulti Affetti da Infezione Cronica da Virus dell¿Epatite C (HCV) di Genotipo 1, 2, 4, 5 o 6 con Cirrosi Compensata e Na¿ve Rispetto al Trattamento.
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberM16-135
    A.5.4Other Identifiers
    Name:N.D.Number:N.D.
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameGlecaprevir/Pibrentasvir
    D.3.2Product code ABT-493/ABT-530
    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 INNPibrentasvir
    D.3.9.2Current sponsor codeABT-530
    D.3.9.3Other descriptive namePIBRENTASVIR
    D.3.9.4EV Substance CodeSUB180955
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlecaprevir
    D.3.9.2Current sponsor codeABT-493
    D.3.9.4EV Substance CodeSUB180954
    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 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
    HCV
    HCV
    E.1.1.1Medical condition in easily understood language
    HCV Genotype 1, 2, 4, 5 or 6 in treatment na¿ve subjects with compensated cirrhosis
    HCV di Genotipo 1,2,4,5 o 6 in soggetti con cirrosi compensata e na¿ve rispetto al trattamento
    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 LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of the SVR12 rates of 8 weeks of treatment with the glecaprevir/pibrentasvir combination regimen to the
    historical SVR12 rate of 12 weeks of treatment with the glecaprevir/pibrentasvir in treatment na¿ve adults with chronic HCV GT 1, 2, 4, 5 or 6 infection and compensated cirrhosis. The primary efficacy objective will be assessed across genotypes, in the Per-Protocol (PP) population.
    To assess the safety of 8 weeks of treatment with the
    glecaprevir/pibrentasvir combination regimen in treatment na¿ve adults with chronic HCV GT 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
    ¿ Dimostrare la non inferiorit¿ dei tassi di risposta SVR12 per il trattamento della durata di 8 settimane con il regime combinato glecaprevir/pibrentasvir rispetto al tasso SVR12 storico ottenuto dal trattamento della durata di 12 settimane con glecaprevir/pibrentasvir in adulti affetti da infezione cronica da virus HCV di genotipo 1, 2, 4, 5 o 6 e cirrosi compensata che sono na¿ve al trattamento. L¿obiettivo primario di efficacia sar¿ valutato in maniera trasversale per tali genotipi nella popolazione PP (per protocol).
    ¿ Valutare la sicurezza del trattamento della durata di 8 settimane con il regime combinato glecaprevir/pibrentasvir in soggetti adulti affetti da infezione cronica da virus HCV di genotipo 1, 2, 4, 5 o 6 e cirrosi compensata, na¿ve al trattamento.
    E.2.2Secondary objectives of the trial
    To demonstrate the non-inferiority of the SVR12 rates of 8 weeks of treatment with the glecaprevir/pibrentasvir combination regimen to the
    historical SVR12 rate of 12 weeks of treatment with the glecaprevir/pibrentasvir in treatment na¿ve adults with chronic HCV GT 1, 2, 4, 5 or 6 infection and compensated cirrhosis based on in the intention-to-treat (ITT) population.
    To assess the percentage of subjects with OTVF across genotypes in the intention-to-treat (ITT) population.
    To assess the percentage of subjects with post-treatment relapse across genotypes in the intention-to-treat (ITT) population.
    - Dimostrare la non inferiorit¿ dei tassi di risposta SVR12 per il trattamento della durata di 8 settimane con il regime combinato glecaprevir/pibrentasvir rispetto al tasso SVR12 storico ottenuto dal trattamento della durata di 12 settimane con glecaprevir/pibrentasvir in adulti affetti da infezione cronica da virus HCV di genotipo 1, 2, 4, 5 o 6 e cirrosi compensata nella popolazione Intention-to-Treat (ITT).
    - Valutare la percentuale di soggetti che manifestano fallimento virologico durante il trattamento (on-treatment virologic failure, OTVF) in maniera trasversale per i genotipi (nella popolazione ITT).
    - Valutare la percentuale di soggetti con recidiva post-trattamento rilevata in maniera trasversale per i genotipi (nella popolazione ITT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age at time of Screening;
    2. Screening laboratory result indicating HCV GT 1, 2, 4, 5 or 6 infection;
    3. Positive plasma HCV antibody and HCV RNA viral load = 1000 IU/mL at Screening;
    4. Treatment-naïve to any approved or investigational anti-HCV medication;
    5. Subject must be documented as cirrhotic, with a Child-Pugh score of = 6.
    1. Soggetti di ambo i sessi, di età pari o superiore a 18 anni al momento dello Screening;
    2. Infezione da HCV di genotipo 1, 2, 4, 5 o 6 confermata dai risultati degli esami di laboratorio eseguiti allo Screening;
    3. Positività plasmatica per anticorpi anti-HCV e carica virale HCV RNA = 1000 UI/mL allo Screening;
    4. Soggetti naïve rispetto al trattamento con qualsiasi medicinale anti-HCV approvato o sperimentale;
    5. Soggetti per cui sia disponibile evidenza di cirrosi, con un punteggio Child-Pugh = 6.
    E.4Principal exclusion criteria
    1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug;
    2. Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification,
    hepatic encephalopathy or variceal bleeding, radiographic evidence ofsmall ascites, or empiric use of lactulose/rifaximin. The use of beta blockers is not exclusionary;
    3. Current HBV or HIV infection on screening tests, defined as:
    • A positive HBsAg, or;
    • HBV DNA > LLOQ in subjects with isolated positive anti-HBc (i.e.,
    negative HBsAg and Anti-HBs), or;
    • A positive anti-human immunodeficiency virus antibody (HIV Ab).
    4. HCV genotype performed by the central laboratory during screening indicating genotype 3 infection or co-infection with more than one HCV genotype;
    5. Screening laboratory analyses showing any of the following abnormal laboratory results:
    • Alanine aminotransferase ALT > 10 × ULN
    • Aspartate aminotransferase AST > 10 × ULN
    • Total Bilirubin > 3.0 mg/dL
    • Calculated creatinine clearance (CrCl, Cockcroft-Gault method) of < 50
    mL/min
    • Albumin < 2.8 mg/dL
    • Hemoglobin < 10 g/dL
    • Platelets < 50,000 cells/mm3
    6. History of suspected or confirmed hepatocellular carcinoma.
    1. Soggetto di sesso femminile in gravidanza, in allattamento o che intenda iniziare una gravidanza nel corso della sperimentazione o nei circa 30 giorni dopo l’ultima dose del medicinale sperimentale;
    2.Qualsiasi evidenza clinica attuale o pregressa di cirrosi scompensata, compresa qualsiasi evidenza attuale o pregressa di Child-Pugh B o C, encefalopatia epatica oppure emorragia da varici, evidenza radiografica di ascite di grado lieve oppure uso empirico di lattulosio/rifaximina. L’uso di betabloccanti non rappresenta un criterio di esclusione;
    3. Presenza attuale di infezione da HBV oppure HIV rilevata durante il periodo di Screening , definita come:
    • Positività per HBsAg, oppure;
    • HBV DNA > LLOQ in soggetti con positività isolata dell’anti-HBc (ovvero, negatività per HBsAg ed Anti- HBs), oppure;
    • Positività per HIV Ab (anticorpi anti-HIV).
    4. Infezione da virus HCV di genotipo 3 confermata dal laboratorio centrale nel corso dello Screening oppure presenza di coinfezione con più di un genotipo del virus HCV;
    5. Risultati delle analisi di laboratorio che indicano una delle seguenti alterazioni:
    • Alanina aminotransferasi ALT > 10 × ULN
    • Aspartato aminotransferasi AST > 10 × ULN
    • Bilirubina Totale > 3,0 mg/dl
    • Clearance della creatinina (CrCl calcolata mediante formula di Cockcroft-Gault) < 50 ml/min
    • Albumina < 2,8 mg/dl
    • Emoglobina < 10 g/dl
    • Piastrine < 50.000 cell/mm3
    6. Storia di sospettato o confermato carcinoma epatocellulare
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the percentage of subjects who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) across genotypes.
    L’obiettivo primario di efficacia consiste nella percentuale di soggetti che raggiungono la risposta SVR12 (HCV RNA < LLOQ 12 settimane dopo l'ultima dose attuale di farmaco sperimentale) in maniera trasversale nei genotipi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks following the last dose of study drug
    12 settimane dopo l'ultima dose attuale di farmaco sperimentale
    E.5.2Secondary end point(s)
    - SVR12 (HCV RNA<LLOQ 12 weeks after the last actual dose of study drug) for the subjects in the Intention-to-Treat population.
    - The percentage of subjects with HCV on-treatment virologic failure.
    - The percentage of subjects with post-treatment HCV relapse.
    - Tassi di SVR12 (HCV RNA< LLOQ 12 settimane dopo l'ultima dose attuale di farmaco sperimentale) per i soggetti nella popolazione Intention-to-Treat (ITT).
    - Percentuale di soggetti che manifestano fallimento virologico durante il trattamento.
    - Percentuale di soggetti con recidiva post-trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks following the last dose of study drug for Secondary Endpoint 1 and 2; 24 weeks following the last dose of study drug for Secondary Endpoint 3.
    12 settimane dopo l'ultima dose di farmaco sperimentale per l'end point secondario 1 e 2; 24 settimane dopo l'ultima dose di farmaco sperimentale per l'end point secondario 3
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA65
    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
    Canada
    Israel
    Mexico
    Puerto Rico
    Taiwan
    United States
    Vietnam
    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
    LSLV
    LSLV
    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 months7
    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 months7
    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: 225
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 275
    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 Decision2017-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
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