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    Summary
    EudraCT Number:2016-002491-26
    Sponsor's Protocol Code Number:M15-942
    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:2016-10-26
    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 number2016-002491-26
    A.3Full title of the trial
    An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
    Estudio abierto y multicéntrico para evaluar la eficacia y la seguridad de ABT-493/ABT-530 en combinación con sofosbuvir y ribavirina en pacientes con infección crónica por el virus de la hepatitis C (VHC) que han presentado fracaso virológico en estudios clínicos del VHC de AbbVie (MAGELLAN-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies
    Estudio abierto para evaluar la eficacia y seguridad de ABT-493/ABT-530 en combinación con sofosbuvir y ribavirina en pacientes con infección crónica por el virus de la hepatitis C (VHC) que han presentado fracaso virológico en estudios clínicos del VHC de AbbVie
    A.4.1Sponsor's protocol code numberM15-942
    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+34901 20 01 03
    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.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 Yes
    D.2.1.1.1Trade name Sovaldi
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    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 nameSofosbuvir
    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 INNSOFOSBUVIR
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeSOFOSBUVIR
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 3
    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.2.5The 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 nameRibavirin
    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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.2Current sponsor codeRIBAVIRIN
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Hepatitis C
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis caused by infection of the Hepatitis C virus
    Hepatitis cronica causada por la infección del virus de la Hepatitis C
    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 by evaluating the percentage of subjects achieving a 12-week post-treatment sustained virologic failure response (SVR12) in each treatment arm and safety of ABT-493/ABT-530 plus SOF and RBV in adults with chronic HCV GT1-6 infection who previously failed HCV treatment in an AbbVie HCV clinical study, designated as an AbbVie HCV parent study.
    El objetivo principal de este estudio es evaluar la eficacia determinando el porcentaje de pacientes que presenten una respuesta virológica sostenida a las 12 semanas postratamiento (RVS12) en cada grupo de tratamiento y la seguridad de ABT-493/ABT-530 más SOF y RBV en adultos con infección crónica por el VHC GT1-6 en los que ha fracasado el tratamiento previo para el VHC en un estudio clínico del VHC de AbbVie.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess the percentage of subjects with HCV on-treatment virologic failure, and the percentage of subjects with HCV virologic relapse.
    Los objetivos secundarios son evaluar el porcentaje de pacientes con fracaso virológico durante el tratamiento y el porcentaje de pacientes con recidiva virológica del VHC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, who experienced virologic failure during or after treatment with ABT 493/ABT-530 in an AbbVie HCV parent study. Subjects who have received virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), ombitasvir/paritaprevir/r (2D) in AbbVie HCV parent study may be enrolled at AbbVie's discretion.
    2. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
    3. Cirrhotic Subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
    4. Cirrhotic Subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.
    1. Varones o mujeres que presentaron fracaso virológico durante o después del tratamiento con ABT 493/ABT-530 en un estudio original del VHC de AbbVie. A discreción de AbbVie, podrán incluirse pacientes que presentaron fracaso virológico durante o después de un tratamiento con ombitasvir/paritaprevir/r + dasabuvir (3D) u ombitasvir/paritaprevir/r (2D) en un estudio original del VHC de AbbVie.
    2. Los pacientes deben ser capaces de comprender y cumplir el calendario de visitas del estudio y todos los demás requisitos del protocolo.
    3. Los pacientes cirróticos deben tener cirrosis compensada (puntuación de Child-Pugh ≤ 6) en la selección y ninguna evidencia actual o pasada de clasificación de Child-Pugh B o C ni antecedentes clínicos de descompensación hepática, incluidas ascitis (observada en la exploración física), encefalopatía hepática o hemorragia por varices esofágicas.
    4. Los pacientes cirróticos deben mostrar ausencia de carcinoma hepatocelular (CHC), determinada por un resultado negativo en ecografía, tomografía computarizada (TC) o resonancia magnética (RM) en los 3 meses previos a la selección o un resultado negativo en una ecografía en la selección.
    E.4Principal exclusion criteria
    1. History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
    2. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label.
    3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator, and failure in an AbbVie HCV parent study due to non-virologic reasons.
    4. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
    5. Screening laboratory analyses showing creatinine clearance < 30 mg/dL.
    6. Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
    7. Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.
    1. Antecedentes de hipersensibilidad grave o potencialmente mortal o sensibilidad clínicamente significativa a cualquiera de los fármacos del estudio o sus componentes.
    2. Mujeres embarazadas o en lactación o que estén considerando quedarse embarazadas durante el estudio o los 4 meses siguiente a la última dosis de la medicación del estudio, o según lo indicado en la ficha técnica local de RVB.
    3. Antecedentes recientes (en los 6 meses previos a la administración de la medicación del estudio) de abuso de alcohol o drogas que en opinión del investigador podrían impedir el cumplimiento del protocolo, o fracaso en un estudio original del VHC de AbbVie debido a motivos no virológicos.
    4. Resultado positivo en el análisis del antígeno de superficie del virus de la hepatitis B (HBsAg) en la selección.
    5. Análisis clínicos en la selección que indiquen un aclaramiento de creatinina < 30 mg/dl.
    6. Retirada del estudio original del VHC de AbbVie por motivos distintos del fracaso virológico (p. ej., falta de cumplimiento, pérdida para el seguimiento y/o aparición de un acontecimiento adverso).
    7. Recepción de cualquier tratamiento para el VHC después del fracaso del régimen de tratamiento en el estudio original del VHC de AbbVie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects in the ITT population who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug), by treatment arm and overall. The number and percentage of subjects achieving SVR12 will be summarized along with a two-sided 95% confidence interval using the normal approximation to the binomial distribution, unless the rate for SVR12 is 100%, then the Wilson's score method will be used for the confidence interval instead.
    A summary of reason for SVR12 non-response (e.g., on-treatment virologic failure, relapse, other) will be provided.
    La variable principal de eficacia es el porcentaje de pacientes en la población ITT con RVS12 (ARN del VHC< LIC 12 semanas después de la última dosis real de fármaco del estudio) en cada grupo de tratamiento y globalmente. Se resumirán el número y el porcentaje de los pacientes que logren RVS12 junto con el intervalo de confianza del 95% bilateral mediante la aproximación normal a la distribución binomial, a menos que la tasa de RVS12 sea del 100%, en cuyo caso se utilizará el método de puntuación de Wilson para calcular el intervalo de confianza.
    Se proporcionará un resumen con las razones de no respuesta a SVR12 (p.ej. fracaso virológico durante el tratamiento, recidiva, otros)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drugs
    12 semanas después de la última dosis del fármaco del estudio
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • The percentage of subjects with on-treatment HCV virologic failure in each treatment arm and overall;
    • The percentage of subjects with post-treatment HCV virologic relapse in each treatment arm and overall.


    For the analysis of HCV virologic relapse, completion of treatment is defined as any subject with study drug duration of 77 days and 105 days or greater for subjects allocated to treatment durations of 12 weeks and 16 weeks, respectively.
    For each treatment arm and overall, as applicable, the number and percentage of subjects meeting each secondary efficacy endpoint will be summarized along with a two-sided 95% confidence interval using Wilson's score method.
    Las variables secundarias son:
    • Porcentaje de pacientes con fracaso virológico durante el tratamiento, en cada grupo de tratamiento y globalmente;
    • Porcentaje de pacientes con recidiva virológica del VHC después del tratamiento, en cada grupo de tratamiento y globalmente.

    Para el análisis de la recaida virológica del VHC, tratamiento completo se define como cualquier paciente que haya completado el tratamiento durante 77 dias y 105 dias o más para pacientes asignados a 12 y 16 semanas de tratamiento respectivamente.

    Para cada grupo de tratamiento y globalmente, se resumirán el número y el porcentaje de pacientes que cumplan cada criterio de valoración secundario de la eficacia, junto con el intervalo de confianza del 95% bilateral utilizando el método de puntuación de Wilson
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment, and end of treatment to 24 weeks post treatment
    Desde el día 1 de tratamiento hasta el fin de tratamiento, y fin de tratamiento a las 24 semanas
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    New Zealand
    Switzerland
    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
    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 months4
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days16
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    AbbVie does not plan to offer any additional therapies after the subject's last study visit of the Post-Treatment Period.
    AbbVie no planea ofrecer ninguna terapia adicional después de la última visita del paciente del periodo post-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 Decision2016-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-30
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