Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005777-27
    Sponsor's Protocol Code Number:M20-350
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-07-07
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005777-27
    A.3Full title of the trial
    A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection
    Étude prospective multicentrique, à bras unique, évaluant la sécurité et l’efficacité d’un traitement de 8 semaines par GLE/PIB chez des patients adultes et adolescents présentant une infection aiguë par le virus de l’hépatite C (VHC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, single-arm prospective study to determine safety and efficacy of GLE/PIB 8-week treatment in adults and adolescents acutely infected with hepatitis C virus
    Étude prospective multicentrique, à bras unique pour déterminer l'innocuité et l'efficacité d'un traitement pendant 8 semaines par GLE/PIB chez les adultes et les adolescents avec une infection aiguë par le virus de l'hépatite C
    A.4.1Sponsor's protocol code numberM20-350
    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 pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 561090
    B.5.5Fax number+44 1628 461153
    B.5.6E-mailglobal-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 Yes
    D.2.1.1.1Trade name Maviret
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form 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.3.9.3Other descriptive nameGLE
    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 number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIBRENTASVIR
    D.3.9.3Other descriptive namePIB
    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 number120
    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
    Hepatitis C Virus
    Virus de l'Hépatite C
    E.1.1.1Medical condition in easily understood language
    HCV
    VHC
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 of this study is to demonstrate the efficacy of 8-week treatment with GLE/PIB in adults and adolescents with confirmed acute HCV infection by comparing the SVR12 rate from this study to the historical SVR12 rate in subjects with chronic HCV infection who were treated with GLE/PIB. The primary efficacy objective will be assessed based on the ITT population which is defined as all enrolled subjects who received at least 1 dose of study drug.
    L’objectif principal de cette étude est de démontrer l’efficacité de 8 semaines de traitement par GLE/PIB chez des adultes et des adolescents atteints d’une infection aiguë par le VHC confirmée, en comparant le taux de RVS12 de cette étude au taux historique de RVS12 chez des patients traités par GLE/PIB pour une hépatite C chronique. L’objectif principal d’efficacité sera évalué sur la base de la population ITT, définie comme l’ensemble des patients inclus ayant reçu au moins une dose du médicament expérimental.
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is the same as the primary objective of this study except that the key secondary objective will be assessed in the modified ITT – virologic failure (mITT-VF) population. The mITT-VF population is defined as all enrolled subjects who received at least one dose of study drug, excluding those who did not achieve SVR12for reasons other than virologic failure (i.e., those with HCV reinfection, those who did not achieve SVR12due to early premature discontinuation of study drug, and those who were missing HCV RNA data in the SVR12window after backward imputation).

    The other secondary objectives of this study are to determine the on-treatment virologic failure, post-treatment relapse, and post-treatment reinfection rates in the ITT population.
    Le principal objectif secondaire de l’étude est identique à l’objectif principal, à la différence qu’il sera évalué dans la population ITT modifiée - échec virologique (ITTm-EV). La population ITTm-EV se définit comme l’ensemble des patients inclus ayant reçu au moins une dose du médicament expérimental, à l’exclusion des patients qui n’auront pas atteint la RVS12 pour une raison autre qu’un échec virologique (à savoir, réinfection par le VHC, absence de RVS12 en raison d’un arrêt prématuré du médicament expérimental, et valeurs d’ARN du VHC manquantes dans la fenêtre de RVS12 après imputation rétrograde).

    Les autres objectifs secondaires de l’étude consistent à déterminer le taux d’échec virologique sous traitement, le taux de rechute post-traitement et le taux de réinfection post-traitement dans la population ITT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult or adolescent, age 12 years and older weighing at least 45 kg.
    - Subject must have evidence of acute HCV infection prior to enrollment. Evidence of acute HCV infection is defined as physician diagnosis of
    acute HCV infection and at least 1 of the following:
    - Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening OR Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to Screening.
    - Subject must be HCV treatment-naïve, defined as no prior treatment including interferon for this HCV infection.
    - Subject must be documented as either having no cirrhosis or as having compensated cirrhosis.
    - Absence of hepatocellular carcinoma (HCC) for subjects with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Subject who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
    - No history of liver decompensation
    - Patient adulte ou adolescent, âgé de 12 ans et plus et pesant au moins 45 kg.
    - Preuve d’une infection aiguë par le VHC avant l’inclusion, ç.-à-d. diagnostic d’infection aiguë par le VHC établi par un médecin, associé à au moins 1 des critères suivants :
    - Résultats négatifs pour l’anticorps anti-VHC, l’ARN du VHC et/ou l’antigène de capside du VHC suivis de résultats positifs pour l’ARN du VHC ou l’antigène de capside du VHC, le tout dans un délai de 8 mois avant la sélection ;
    - OU Résultats négatifs pour l’anticorps anti-VHC, l’ARN du VHC et/ou l’antigène de capside du VHC suivis de résultats positifs pour l’ARN du VHC ou l’antigène de capside du VHC, le tout dans un délai de 11 mois avant la sélection, ET comportement à risque d’infection au VHC dans les 6 mois précédant l’obtention des résultats positifs pour l’ARN du VHC ou l’antigène de capside du VHC ;
    - OU Signes et symptômes cliniques compatibles avec une hépatite aiguë (ALAT > 5 × LSN et/ou ictère) en l’absence d’antécédents de pathologie hépatique chronique ou d’une autre cause d’hépatite aiguë, et résultats positifs pour l’ARN du VHC ou l’antigène de capside du VHC, le tout dans un délai de 8 mois précédant la sélection, ET comportement à risque d’infection au VHC dans les 6 mois précédant l’obtention des résultats positifs pour l’ARN du VHC ou l’antigène de capside du VHC ;
    - OU Résultats négatifs pour l’anticorps anti-VHC et positifs pour l’ARN du VHC ou l’antigène de capside du VHC dans un délai de 5 mois précédant la sélection.
    - Aucun traitement antérieur, y compris par interféron, pour l’infection par le VHC actuelle.
    - Absence de cirrhose ou présence d’une cirrhose compensée, documentée.
    - Absence de carcinome hépatocellulaire (CHC) pour les patients cirrhotiques confirmée par un examen échographique, tomodensitométrique (TDM) ou d’imagerie par résonance magnétique (IRM) négatif dans les 3 mois précédant la sélection, ou par un examen échographique négatif lors de la sélection. Si l’échographie est positive et révèle une suspicion de CHC qui est par la suite écartée par un résultat négatif à la TDM, à l’IRM ou à la biopsie, le patient peut être inclus dans l’étude.
    - Absence d’antécédents de décompensation hépatique.
    E.4Principal exclusion criteria
    - Evidence of chronic HCV infection for this HCV infection.
    - Subject has a history of severe life-threatening or other significant sensitivity to any excipients of the study drug.
    - Subject has cause of liver disease other than HCV infection
    - Subject has uncontrolled drug use that may impair protocol compliance in the
    opinion of the investigator.
    - Female who is pregnant or breastfeeding; or is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug.
    - Subject must require chronic use of systemic immunosuppressants during the study
    - Preuve d’une infection chronique pour l'infection par le VHC actuelle.
    - Antécédents d’hypersensibilité menaçant le pronostic vital ou de sensibilité significative aux excipients du médicament expérimental.
    - Facteurs de risque de maladie hépatique autres que l’infection par le VHC.
    - Consommation de drogues incontrôlée susceptible de compromettre le respect du protocole, de l’avis de l’investigateur.
    - Patiente femme, enceinte ou allaitante, ou qui envisage une grossesse ou de donner ses ovocytes pendant l’étude et pendant environ 30 jours après la dernière administration du médicament expérimental.
    - L’état de santé du patient nécessite la prise chronique d’immunosuppresseurs systémiques pendant l’étude.



    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the achievement of SVR12(defined as HCV RNA < the lower limit of quantification [LLOQ] 12 weeks after the last actual dose of study drug) for each subject in the ITT population.
    Le critère d’évaluation principal est l’obtention d’une RVS12 (définie comme un taux d’ARN du VHC < LLOQ 12 semaines après l’administration de la dernière dose effective du médicament expérimental), pour chaque patient de la population ITT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment; end of treatment to post treatment week 12
    Du jour 1 du traitement à la fin du traitement; de la fin du traitement à la semaine 12 post-traitement
    E.5.2Secondary end point(s)
    The key secondary endpoint is achievement of SVR12for each subject in the mITT-VF population.
    Le principal critère d’évaluation secondaire est l’obtention d’une RVS12, pour chaque patient de la population ITTm-EV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment; end of treatment to post treatment week 12
    Du jour 1 du traitement à la fin du traitement; de la fin du traitement à la semaine 12 post-traitement
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    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
    Last subject's last visit
    Dernière Visite du Dernier Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 15
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 253
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors & People Who Inject Drugs (PWID)
    Mineurs & Usagers de Drogues Injectables (UDI)
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 283
    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.
    À la fin du traitement, les patients sont suivis pendant 12 semaines après la dernière dose du médicament à l'étude. Les schémas de traitement ultérieurs seront à la discrétion de l'investigateur.
    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 Decision2021-09-06
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 20 04:33:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA