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    Summary
    EudraCT Number:2016-004876-23
    Sponsor's Protocol Code Number:M16-133
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-004876-23
    A.3Full title of the trial
    A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir(GLE)/Pibrentasvir(PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1 – 6 Infection and Aspartate aminotransferase to Platelet Ratio Index (APRI) ≤ 1
    Estudio multicéntrico, abierto y de un solo brazo para evaluar la eficacia y la seguridad de glecaprevir (GLE)/pibrentasvir (PIB) en adultos con infección crónica por el virus de la hepatitis C (VHC) de genotipos 1-6 y un índice aspartato aminotransferasa/plaquetas (APRI) ≤ 1 no tratados previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to evaluate Glecaprevir/Pibrentasvir in adults with Chronic Hepatitis C Virus Genotype 1-6 infection, with APRI (a predictor of hepatic fibrosis) ≤ 1, who have never received HCV treatment
    Estudio para evaluar Glecaprevir/Pibrentasvir en adultos con infección crónica por el virus de la hepatitis C de genotipos 1-6, con APR (un indicador de fibrosis hepática) ≤1, que nunca han recibido tratamiento para VHC.
    A.4.1Sponsor's protocol code numberM16-133
    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
    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 number+34901 200 103
    B.5.6E-mailabbvie_reec@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 INNGlecaprevir
    D.3.9.2Current sponsor codeABT-493
    D.3.9.3Other descriptive nameGLECAPREVIR
    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.3.8 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.3.11 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 infection
    Infección crónica por el virus de la hepatitis C
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C infection
    Infección crónica por el virus de la hepatitis C
    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 10019751
    E.1.2Term Hepatitis C virus
    E.1.2System Organ Class 100000074171
    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 efficacy (by achieving high sustained virologic response 12 weeks post dosing [ SVR12] rate) and safety of 8 weeks of treatment with the GLE/PIB combination regimen in treatment naïve adults with HCV GT 1 - GT6 infection with APRI ≤ 1. The primary efficacy objective will be assessed based on modified intention-to-treat (mITT) population across genotypes HCV GT1 - GT6.
    Demostrar la eficacia (si se alcanza una respuesta virológica sostenida alta 12 semanas después del tratamiento [RVS12]) y la seguridad de 8 semanas de tratamiento con la combinación de GLE/PIB en pacientes adultos con infección por el VHC de GT1-GT6 con APRI ≤ 1 no tratados previamente. El objetivo principal de eficacia se evaluará en base a la población con los genotipos GT1-GT6 infectada por VHC por intención de tratar modificada (ITm).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To demonstrate the efficacy (by achieving high SVR12 rate) of 8 weeks of treatment with the GLE/PIB combination regimen in treatment naïve adults with HCV GT1 - GT6 infection with APRI ≤ 1 based on ITT population.
    • Assess the percentage of subjects with HCV on-treatment virologic failures across GTs in adults with HCV GT1 - GT6 infection with APRI ≤ 1 based on ITT population.
    • Assess the percentage of subjects with HCV virologic relapse across GTs in adults with HCV GT1 - GT6 infection with APRI ≤ 1 based on ITT population.
    Los objetivos secundarios del estudio son:
    • Demostrar la eficacia (si se alcanza una RVS12 alta) de 8 semanas de tratamiento con la combinación de GLE/PIB en pacientes adultos con infección crónica por el VHC de GT 1-6 y APRI ≤ 1 no tratados previamente con base en la población con IT.
    • Evaluar el porcentaje de fracaso virológico en sujetos adultos infectados con VHC con GTs GT1-GT6 en tratamiento, con APRI ≤ 1 basado en la población con IT.

    • Evaluar el porcentaje de recaídas en sujetos adultos infectados con VHC con GTs GT1-GT6 con APRI ≤ 1 basado en la población IT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female, at least 18 years old at the time of screening.
    2. Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug:
    • Platelets ≥ 150.000 cells/mm3
    • Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) ≤ 10 × ULN
    • Direct bilirubin ≤ ULN
    • Albumin ≥ lower limit of normal (LLN)
    • Calculated creatinine clearance (using Cockcroft-Gault method) ≥ 30 mL/min
    • A negative hepatitis B surface antigen (HBsAg), and negative anti-hepatitis B core(HBc) or; hepatitis B virus (HBV) DNA < LLOQ in subjects with isolated positive anti-HBc (i.e., negative HBsAg and Anti hepatitis B surface [HBs])
    3. Positive anti- HCV antibody (Ab) AND Plasma HCV RNA viral load ≥ 1000 IU/mL at Screening.
    4. Any HCV GT allowed, including HCV GT1-, 2-, 3-, 4-, 5-, and/or 6-infection. Mixed GT and indeterminate GT may be acceptable.
    5. APRI SCORE ≤ 1, at time of Screening
    6. Subject is treatment naïve, e.g., has never received any other investigational or commercially available anti-HCV agents (e.g.,interferon, peginterferon, ribavirin [RBV], telaprevir, boceprevir, simeprevir, asunaprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir, dasabuvir, voxilaprevir or any other anti-HCV agent that is approved during the study).
    1. Varones o mujeres adultos con una edad mínima de 18 años en el momento de la selección.
    2. Valores analíticos que cumplan los siguientes criterios durante el período de selección, antes de la primera dosis del fármaco del estudio:
    • Plaquetas ≥ 150 000 células/mm3
    • Alanina aminotransferasa (ALT) ≤ 10 veces el límite superior de la normalidad (LSN)
    • Aspartato aminotransferasa (AST) ≤10 x LSN
    • Bilirrubina directa ≤ LSN
    • Albúmina ≥ límite inferior de la normalidad (LIN)
    • Aclaramiento de creatinina calculado (mediante el método de Cockcroft-Gault) ≥ 30 ml/min
    • Resultado negativo para el antígeno de superficie de la hepatitis B (HBsAg) y para anticuerpos contra el antígeno nuclear de la hepatitis B (HBc); o ADN del virus de la hepatitis B (VHB) < LIC en pacientes con resultado positivo para anticuerpos anti-HBc aislados (es decir, resultado negativo para HBsAg y anticuerpos contra el antígeno de superficie de la hepatitis B [HBs]).
    3. Resultado positivo para anticuerpos (Ac) anti-VHC Y concentración vírica de ARN del VHC en plasma ≥ 1000 UI/ml en la selección.
    4. Infección por VHC de cualquiera de los GT permitidos, incluidos los GT 1, 2, 3, 4, 5 y 6. Se podrá aceptar un GT mixto y un GT indeterminado.
    5. Puntuación APRI ≤ 1 en el momento de la selección.
    6. El paciente no ha sido tratado previamente, es decir, nunca ha recibido ningún otro fármaco contra el VHC en investigación o comercializado (por ejemplo, interferón, peginterferón, ribavirina [RBV], telaprevir, boceprevir, simeprevir, asunaprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir, dasabuvir, voxilaprevir ni ningún otro fármaco anti-VHC aprobado durante el estudio).
    E.4Principal exclusion criteria
    1. Cirrhosis or past evidence of cirrhosis, described as:
    • previous histologic diagnosis of cirrhosis on liver biopsy, e.g., METAVIR, Batts-Ludwig, Knodell, IASL, Scheuer, or Laennec fibrosis score of > 3, Ishak score of > 4 in any liver biopsy conducted prior to screening, OR
    • Any previous transient elastography score of ≥ 12.5 kPa, OR
    • Any current or historical clinical evidence of cirrhosis or decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of ascites; or use of lactulose and/or rifaximin for hepatic encephalopathy prophylaxis or treatment.
    2. History of hepatocellular carcinoma (HCC)
    1. Cirrosis o evidencias previas de cirrosis, descritas como:
    • diagnóstico histológico previo de cirrosis en biopsia hepática, por ejemplo, puntuación > 3 en las escalas METAVIR, Batts-Ludwig, Knodell, IASL, Scheuer para la fibrosis, puntuación > 4 en la escala Ishak en cualquier biopsia hepática realizada antes de la selección, O
    • cualquier puntuación ≥ 12,5 kPa en una elastografía de transición previa, O
    • cualquier indicio actual o histórico de cirrosis o cirrosis descompensada, incluido cualquier indicio actual o pasado de grado B o C en la clasificación de Child-Pugh, encefalopatía hepática o varices hemorrágicas, signos radiológicos de ascitis o uso de lactulosa o rifaximina para la profilaxis o el tratamiento de una encefalopatía hepática.

    2. Antecedentes de carcinoma hepatocelular (CHC)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) across genotypes in adults with HCV GT1 - GT6 based on mITT population.
    El criterio de valoración principal de la eficacia es el porcentaje de pacientes que alcanza la RVS12 (ARN del VHC < límite inferior de cuantificación [LIC] 12 semanas después de la administración de la última dosis real del fármaco del estudio) en los distintos genotipos GT1-GT6 en adultos con infección por el VHC basada en la población con ITm
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last dose of study drug
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    • Percentage of subjects who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) across GTs in adults with HCV GT1 - GT6 based on ITT population
    • Percentage of subjects with on-treatment virologic failure based on ITT population
    • Percentage of subjects with post-treatment relapse based on ITT population
    Los criterios de valoración secundarios son:
    • Porcentaje de sujetos adultos que alcanzan SVR12 (ARN del VHC < límite inferior de cuantificación [LIC] 12 semanas después de la administración de la última dosis real del fármaco del estudio) con GTs GT1-GT6, con infección por el VHC basado en población con IT.
    • Porcentaje de sujetos en tratamiento con fracaso virológico basado en población con IT.
    • Porcentaje de recaídas en sujetos post-tratamiento basadas en población con IT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment and end of treatment to 12 weeks after the last dose of study drug.
    Del Día 1 de tratamiento al fin del tratamiento y del fin del tratamiento a las 12 semanas después de la administración de la última dosis del fármaco del estudio.
    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 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 EEA24
    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
    Canada
    Puerto Rico
    Russian Federation
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 207
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 230
    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)
    Upon completion of treatment, subjects are followed for 12 weeks after the last dose of study drug. Additional plans for treatment will be at the investigator's discretion.
    Al finalizar el tratamiento, los sujetos serán seguidos durante 12 semanas después de la última dosis del fármaco del estudio. Planes adicionales para el tratamiento serán a criterio del investigador.
    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 Decision2017-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-13
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