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    Summary
    EudraCT Number:2015-002350-13
    Sponsor's Protocol Code Number:M15-410
    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:2015-10-30
    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 number2015-002350-13
    A.3Full title of the trial
    A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
    Estudio aleatorizado, abierto, multicéntrico para evaluar la eficacia, seguridad y farmacocinética de la coadministración de ABT-493 y ABT-530 (o ABT-493/ABT-530), con y sin ribavirina, en adultos con infección crónica por virus de la hepatitis C (VHC) en quienes fracasó un tratamiento previo con antivirales de acción directa (AAD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic HCV Who Failed a Prior DAA Containing Therapy
    Estudio para evaluar la Eficacia, Seguridad y Farmacocinética de ABT-493 y ABT-530 (o ABT-493/ABT-530)con o sin Ribavirina, en pacientes adultos con VHC Crónica que hayan fallado a otros tratamientos previos con AADs.
    A.4.1Sponsor's protocol code numberM15-410
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446717
    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 number+34901200103
    B.5.5Fax number+441628461153
    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 nameABT-493/ABT-530
    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 INNABT-493
    D.3.9.2Current sponsor codeABT-493
    D.3.9.3Other descriptive nameABT-493
    D.3.9.4EV Substance CodeSUB131084
    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 INNABT-530
    D.3.9.2Current sponsor codeABT-530
    D.3.9.3Other descriptive nameABT-530
    D.3.9.4EV Substance CodeSUB131083
    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
    Hepatitis C Virus (HCV)
    Virus Hepatitis C (VHC)
    E.1.1.1Medical condition in easily understood language
    HCV Genotype 1 or 4, 5, 6
    VHC Genotipo 1 o 4,5,6
    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 objectives of this study are to assess the efficacy and safety of ABT-493 and ABT-530 (or ABT-493/ABT-530 in Part 2) with and without ribavirin (RBV; in Part 1) in DAA treatment-experienced non-cirrhotic or cirrhotic (Part 2) adults with chronic HCV infection.
    El objetivo primario de este estudio es evaluar la eficacia y seguridad de ABT-493 y ABT-530 (o ABT-493/ABT-530 en Parte 2) con y sin ribavirina (RBV; en Parte 1) en Pacientes adultos con infección crónica por VHC no cirróticos o cirróticos (Parte 2) tratados previamente con AAD.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to characterize the pharmacokinetics of DAAs including ABT-493, ABT-530, and RBV (if applicable), and to evaluate the contribution of RBV in Part 1.
    Los objetivos secundarios son caracterizar la farmacocinética de los AADs incluyendo ABT-493, ABT-530 y RBV (si aplica) y evaluar la contribución de la RBV en la Parte 1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Previous treatment with DAA-containing regimen for chronic HCV, genotype 1 (Part 1 and 2) or chronic HCV genotype 4, 5, 6 (Part 2) -infection resulting in either on-treatment virologic failure or post-treatment relapse
    2.Chronic HCV GT1-infection in Part 1 or HCV GT 1 or 4-6 in Part 2.
    1. Tratamiento previo con un régimen que contenga AAD para VHC crónica, genotipo 1 (Parte 1 y Parte 2) o VHC crónico genotipos 4,5,6 (Parte 2). Infección resultante de un fallo virológico al tratamiento o una recaída en postratamiento.
    2. Infección Crónica por VHC GT1 en la parte 1 o VHC G1 o 4-6 en parte 2.
    E.4Principal exclusion criteria
    1.History of severe, life-threatening or other significant sensitivity to any drug
    2.Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
    3.Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
    4.Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
    5.Co-infection with more than one HCV genotype
    1. Antecedentes de sensibilidad grave, potencialmente mortal o importante a otro nivel a cualquier fármaco.
    2. Mujeres embarazadas, que planeen quedarse embarazadas durante el estudio o en período de lactancia o varones cuya pareja esté embarazada o planee quedarse embarazada durante el estudio.
    3. Antecedentes recientes (en los 6 meses previos a la administración del fármaco del estudio) de alcoholismo o toxicomanía que, en opinión del investigador, puedan impedir el cumplimiento del protocolo.
    4. Resultado positivo en el análisis del antígeno de superficie del virus de la hepatitis B (HbsAg) o de anticuerpos contra el virus de la inmunodeficiencia humana (Ac anti VIH).
    5. Co-infección con más de un genotipo del VHC.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).
    La variable primaria de eficacia es RVS12 (VHC ARN < LLOQ 12 semanas después de la última dosis real del estudio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks following last dose of study drug
    12 semanas tras la última dosis de la medicación de estudio
    E.5.2Secondary end point(s)
    SVR4 (HCV RNA < LLOQ 4 weeks after the last actual dose of study drug);
    On-treatment virologic failure;
    Post-treatment relapse
    RVS4 (VHC ARN < LLOQ 4 semanas después de la última dosis real de la medicación del estudio
    En fallo virológico al tratamiento
    Recaida en postratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks following last subject last dose of study drug
    4 semanas tras la última dosis del último paciente
    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 No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    New Zealand
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months2
    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 months2
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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)
    If the treatment is prematurely discontinued, at the subject's last study visit, the investigator will discuss the appropriate subsequent treatment options with the subject depending on available data at the time of failure.

    AbbVie does not plan to offer any additional therapies after the subject's last study visit in the Post-Treatment Period.
    Si el tratamiento es discontinuado prematuramente, en la última visita del estudio del paciente, el investigador discutirá las subsecuentes opciones de tratamiento apropiadas para el paciente dependiendo de los datos disponibles en el momento del fallo al tratamiento.

    Abbvie no planea ofrecer terapias adicionales tras la última visita del paciente del periodo de pos tratamiento.
    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 Decision2016-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-23
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    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
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