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    Summary
    EudraCT Number:2018-003171-35
    Sponsor's Protocol Code Number:IgPro20_3007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-003171-35
    A.3Full title of the trial
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
    Estudio para evaluar la eficacia, la seguridad y la farmacocinética de IgPro20 (inmunoglobulina subcutánea, Hizentra®) en adultos con dermatomiositis (DM)
    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 IgPro20 in adults with dermatomyositis (DM)
    Estudio para evaluar la eficacia, la seguridad y la farmacocinética de IgPro20 en adultos con dermatomiositis (DM).
    A.4.1Sponsor's protocol code numberIgPro20_3007
    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 SponsorCSL Behring LLC
    B.1.3.4CountryUnited States
    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 supportCSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Strasse 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number+1610878 4000
    B.5.6E-mailclinicaltrials@cslbehring.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 Hizentra
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring Gmbh
    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 namehuman immunoglobulin G
    D.3.2Product code IgPro20
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman immunoglobulin G
    D.3.9.2Current sponsor codeIgPro20
    D.3.9.3Other descriptive nameHizentra
    D.3.9.4EV Substance CodeSUB127300
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dermatomyositis
    Dermatomiositis.
    E.1.1.1Medical condition in easily understood language
    Dermatomyositis is an uncommon inflammatory disease marked by muscle weakness and a distinctive skin rash.
    La dermatomiositis es una enfermedad inflamatoria poco común caracterizada por debilidad muscular y erupción cutánea distintiva
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001403
    E.1.2Term Adult dermatomyositis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of IgPro20 SC doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS) assessments.
    El objetivo principal de este estudio es evaluar la eficacia de las dosis s.c. de IgPro20 en comparación con el placebo en pacientes adultos con DM, determinada por el estado de respuesta según las evaluaciones de la puntuación de mejoría total (TIS, del inglés Total Improvement Score).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the efficacy, with additional clinical outcome measures, of IgPro20 in comparison to placebo, the safety of IgPro20 in comparison to placebo, and the long-term safety and efficacy of IgPro20
    Los objetivos secundarios del estudio son evaluar: la eficacia, con criterios de valoración clínicos adicionales, de IgPro20 en comparación con el placebo; la seguridad de IgPro20 en comparación con el placebo; y la seguridad y eficacia a largo plazo de IgPro20.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male or female subjects ≥ 18 years of age with diagnosis of at least probable (idiopathic inflammatory myopathies) IIM per EULAR/ACR Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure, and disease severity defined by Physician global visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
    Hombres o mujeres ≥ 18 años de edad con diagnóstico de miopatía inflamatoria idiopática (MII) que se considere como mínimo probable según los criterios de clasificación de EULAR/ACR, que incluye la confirmación de prurito/manifestación de dermatomiositis (DM), actividad de la enfermedad definida por la presencia de prurito/manifestación de DM o una medida objetiva de la actividad de la enfermedad, y gravedad de la enfermedad definida por una puntuación en la escala visual analógica (EVA) global según el médico, con un valor mínimo de 2,0 cm sobre una escala de 10 cm y MMT-8 ≤ 142 o una puntuación de actividad total en CDASI ≥ 14.

    E.4Principal exclusion criteria
    Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
    Miositis asociada al cáncer, indicios de neoplasia maligna o tumores malignos diagnosticados durante los 5 años anteriores, puntuación ≥ 3 en la escala de daño global según el médico (PGD, del inglés Physician Global Damage), o mejoría significativa de importancia clínica entre la visita de selección y el momento basal.
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate
    Tasa de pacientes con respuesta
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 17, 21, and 25
    Semanas 17, 21 y 25.
    E.5.2Secondary end point(s)
    1. Mean Total Improvement Score (TIS),
    2. Point estimates and 95% CI for mean difference (IgPro20 – placebo) in TIS,
    3. Mean changes from Baseline in Manual Muscle Testing (MMT-8),
    4. Point estimates and 95% CI for mean change difference (IgPro20 – placebo) in MMT-8,
    5. Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score,
    6. Point estimates and 95% CI for mean change difference (IgPro20 – placebo),
    7. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% ,
    8. Percentage and 95% CI of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
    9. Point estimates and 95% CI for the odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
    10. Mean TIS throughout the study,
    11. Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points,
    12. Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS,
    13. Percentage of subjects achieving TIS ≥ 20 points at the end of the study participation,
    14. Mean changes in individual CSMs except muscle enzymes and CDASI from Baseline,
    15. Mean changes in individual CSMs except muscle enzymes and CDASI from Week 25,
    16. Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice,
    17. Percentage of subjects meeting DOW at least once, twice, or > twice,
    18. Time to meeting DOW for the first time,
    19. Number of subjects meeting DOW and receiving rescue corticosteroid treatment,
    20. Percentage of subjects meeting DOW and receiving rescue corticosteroid treatment,
    21. Number of subjects who start oral corticosteroid dose taper,
    22. Percentage of subjects who start oral corticosteroid dose taper,
    23. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    24. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    25. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    26. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    27. Percentage of subjects receiving rescue corticosteroid treatment,
    28. Percentage of subjects whose rescue corticosteroid treatment is tapered,
    29. Time to first intake of rescue corticosteroid treatment,
    30. Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L,
    31. Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L,
    32. Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25,
    33. Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25,
    34. Percentage of subjects with Treatment Emergent Adverse Events (TEAEs),
    35. Percentage of subjects with related TEAEs,
    36. Percentage of subjects with serious TEAEs,
    37. Rate of TEAEs per infusion,
    38. Rate of TEAEs per infusion, by severity,
    39. Rate of related TEAEs per infusion,
    40. Rate of serious TEAEs per infusion.
    1. Puntuación media de mejoría total (TIS).
    2. Estimaciones puntuales e IC del 95 % para la diferencia media (IgPro20 – placebo) en TIS.
    3. Cambios medios observados respecto al momento basal en la prueba muscular manual (MMT-8, del inglés Manual Muscle Testing).
    4. Estimaciones puntuales e IC del 95 % para la diferencia en el cambio medio (IgPro20 – placebo) en MMT-8.
    5. Cambios medios observados respecto al momento basal en la puntuación de actividad total en el índice de gravedad y zona de la dermatomiositis cutánea (CDASI, del inglés Cutaneous Dermatomyositis Disease Area and Severity Index).
    6. Estimaciones puntuales e IC del 95 % para la diferencia en el cambio medio (IgPro20 – placebo).
    73 Numero de pacientes que son capaces de reducir la dosis de corticoesteroides orales en ≥ 25%
    8. porcentaje e IC del 95 % de pacientes que son capaces de reducir la dosis de corticoesteroides orales en ≥ 25%
    9. Estimaciones puntuales e IC del 95 % para la razón de posibilidades (IgPro20:Placebo) de pacientes que son capaces de reducir la dosis de corticoesteroides orales en ≥ 25%
    10. TIS medio durante todo el estudio.
    11. Porcentaje de pacientes que alcancen ≥ 20, ≥ 40 y ≥ 60 puntos en TIS.
    12. Tiempo transcurrido hasta alcanzar ≥ 20, ≥ 40 y ≥ 60 puntos por primera vez en TIS.
    13. Porcentaje de pacientes que alcancen o ≥ 20 puntos en TIS al final de su participación en el estudio.
    14. Cambios medios en el conjunto central de medidas (CSM, del inglés Core Set Measures) individuale individual excepto enzimas musculares y CDASI desde la basal
    15. Cambios medios en CSMs individual except enzimas musculares y CDASI desde la semana 25
    16. Número de pacientes que cumplan la definición de deterioro (DOW, del inglés Definition of Worsening) al menos una vez, dos veces o > dos veces.
    17. Porcentaje de pacientes que cumplan la DOW al menos una vez, dos veces, o > dos veces.
    18. Tiempo transcurrido hasta cumplir la DOW por primera vez.
    19. Número de pacientes que cumplan la DOW y reciban tratamiento de rescate con corticosteroides.
    20. Porcentaje de pacientes que cumplan la DOW y reciban tratamiento de rescate con corticosteroides.
    21. Número de pacientes que empiezan a reducir la dosis de corticoesteroides orales.
    22 Porcentaje de pacientes que empiezan a reducir la dosis de corticoesteroides orales.
    23. Numero de pacientes que son capaces de reducir la dosis de corticoesteroides orales en ≥ 25%, ≥ 50%, ≥ 75%
    24. Número de pacientes capaces de reducir la dosis de corticoesteroides orales en ≥ 25%, ≥ 50%, ≥ 75%
    25. porcentaje de pacientes capaces de reducir la dosis de corticoesteroides orales en ≥ 25%, ≥ 50%, ≥ 75%
    26 porcentaje de pacientes capaces de reducir la dosis de corticoesteroides orales en ≥ 25%, ≥ 50%, ≥ 75%
    27 Porcentaje de pacientes que reciban tratamiento de rescate con corticosteroides.
    28. Porcentaje de pacientes con una reducción progresiva de su tratamiento de rescate con corticosteroides.
    29. Tiempo hasta la primera ingesta de tratamiento con corticosteroides de rescate,
    30. Número de pacientes que presenten al menos 1 nivel, 2 niveles o más de 2 niveles de mejoría con respecto al momento basal en los dominios de movilidad, cuidado personal y actividades cotidianas del EQ-5D-5L.
    31. Porcentaje de pacientes que presenten al menos 1 nivel, 2 niveles o más de 2 niveles de mejoría con respecto al momento basal en los dominios de movilidad, cuidado personal y actividades cotidianas del EQ-5D-5L.
    32. Número de pacientes sin reducción en los niveles o con al menos 1 nivel, 2 niveles o más de 2 niveles de mejoría con respecto al momento basal en los dominios de movilidad, cuidado personal y actividades cotidianas del EQ-5D-5L a partir de la semana 25.
    33. Número de pacientes sin reducción en los niveles o con al menos 1 nivel, 2 niveles o más de 2 niveles de mejoría con respecto al momento basal en los dominios de movilidad, cuidado personal y actividades cotidianas del EQ-5D-5L a partir de la semana 25.
    34. Porcentaje de pacientes con acontecimientos adversos durante el tratamiento (AADT).
    35. Porcentaje de pacientes con AADT relacionados.
    36. Porcentaje de pacientes con AADT graves.
    37. Tasa de AADT por infusión.
    38. Tasa de AADT por infusión, según la gravedad.
    39. Tasa de AADT relacionados por infusión.
    40. Tasa de AADT graves por infusión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-9 Up to Week 25,
    10. Baseline up to Week 53,
    11. Up to Week 53,
    12. Up to Week 53,
    13. Up to Week 53,
    14. Up to Week 25,
    15. Week 25 to Week 53,
    16. Week 9 up to Week 25,
    17. Week 9 up to Week 25,
    18. Week 9 up to Week 25,
    19. Week 9 up to Week 25,
    20. Week 9 up to Week 25,
    21. Up to Week 25,
    22. Up to Week 25,
    23. Up to Week 25,
    24. Up to Week 53,
    25. Up to Week 25,
    26. Up to Week 53,
    27. Week 9 up to Week 25,
    28. Week 9 up to Week 25,
    29. Week 9 up to Week 25,
    30. Up to Week 25,
    31. Up to Week 25,
    32. Up to Week 53,
    33. Week 25 up to Week 53,
    34-40. Up to Week 56.
    1-9. Hasta la semana 25.10-Desde el momento basal hasta la semana 53. 11-Hasta la semana 53. 12-Hasta la semana 53. 13-Hasta la semana 53. 14-Hasta la semana 25. 15-Semanas 25 a 53.16-Semana 9 hasta la semana 25. 17-Semana 9 hasta la semana 25. 18-Semana 9 hasta la semana 25. 19-Semana 9 hasta la semana 25.20-Semana 9 hasta la semana 25. 21- Hasta la semana 25.22-Hasta la semana 25.23-Hasta la semana 25. 24-Hasta la semana 53.25-Hasta la semana 25.26-Hasta la semana 53.27-Semana 9 hasta la semana 25. 28-Semana 9 hasta la semana 25.29-Semana 9 hasta la semana 25.30-Hasta la semana 25. 31-Hasta la semana 25. 32-Hasta la semana 53. 33-Semana 25 hasta la semana 53. 34-40. Hasta la semana 56
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA36
    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
    Argentina
    Australia
    Canada
    European Union
    Japan
    Mexico
    Russian Federation
    Switzerland
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months6
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 126
    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
    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 Decision2019-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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