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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7258   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).

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    Summary
    EudraCT Number:2017-002674-39
    Sponsor's Protocol Code Number:ACH471-205
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002674-39
    A.3Full title of the trial
    An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471
    Studio in aperto di fase 2 di prova di concetto (Proof-of-Concept) in pazienti con glomerulopatia C3 (C3G) o glomerulonefrite membranoproliferativa da immunocomplessi (IC-MPGN) trattati con ACH-0144471
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN)
    Studio di somministrazione di ACH-0144471 in pazienti con glomerulopatia C3 (C3G) o glomerulonefrite membranoproliferativa da immunocomplessi (IC-MPGN)
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberACH471-205
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03459443
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1203-9136
    A.5.4Other Identifiers
    Name:N/ANumber:N/A
    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 SponsorACHILLION PHARMACEUTICALS, INC.
    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 supportAchillion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAchillion Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical operations
    B.5.3 Address:
    B.5.3.1Street Address300 George Street
    B.5.3.2Town/ cityNew Haven
    B.5.3.3Post code06511
    B.5.3.4CountryUnited States
    B.5.6E-mailC3GTrialInquiries@achillion.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/1989
    D.3 Description of the IMP
    D.3.1Product nameACH-0144471 compresse
    D.3.2Product code ACH-0144471
    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 INNACH-0144471
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/1989
    D.3 Description of the IMP
    D.3.1Product nameACH-0144471 compresse
    D.3.2Product code ACH-0144471
    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 INNACH-0144471
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/1989
    D.3 Description of the IMP
    D.3.1Product nameACH0144471 compresse
    D.3.2Product code ACH0144471
    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 INNACH-0144471
    D.3.9.1CAS number 1903768-17-1
    D.3.9.2Current sponsor codeACH-0144471
    D.3.9.4EV Substance CodeSUB189885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SNC
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameACT-HIB
    D.3.2Product code [ACT-HIB]
    D.3.4Pharmaceutical form Powder and solvent for suspension 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.3.9.2Current sponsor codeACT-HIB
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 nameBexsero
    D.3.2Product code [Bexsero]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeVaccino contro il meningococco di gruppo B (rDNA, componente, adsorbito)
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 nameMenveo
    D.3.2Product code [Menveo]
    D.3.4Pharmaceutical form Powder and solvent for suspension 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.3.9.2Current sponsor codeMenveo
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePrevenar 13
    D.3.2Product code [Prevenar 13]
    D.3.4Pharmaceutical form Powder for suspension 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.3.9.2Current sponsor codeprevenar 13 sospensione iniettabile
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 nameSigmacillina 1200000 UI/2,5 ml
    D.3.2Product code [Sigmacillina 1200000 UI/2, 5 ml]
    D.3.4Pharmaceutical form Suspension 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.3.9.2Current sponsor codeSigmacillina 1200000 UI/2,5 ml
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 9
    D.1.2 and D.1.3IMP RoleComparator
    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 nameFenossimetilpenicillina
    D.3.2Product code [Fenossimetilpenicillina]
    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.3.9.2Current sponsor codeFenossimetilpenicillina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
    Glomerulopatia C3 (C3G) o glomerulonefrite membranoproliferativa da immunocomplessi (IC-MPGN)
    E.1.1.1Medical condition in easily understood language
    Renal disease with involvement of the immune system
    Malattia renale con interessamento del sistema immunitario
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10018364
    E.1.2Term Glomerulonephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of 12 months of oral ACH-0144471 in patients with C3G or IC-MPGN based on:
    - Renal biopsy results
    - The number and percentage of patients with an improvement relative to baseline in clinical manifestation(s) of C3G (proteinuria and reduced estimated glomerular filtration rate [eGFR])
    Valutare l¿efficacia di 12 mesi di somministrazione di ACH-0144471 per via orale in pazienti con C3G o IC-MPGN sulla base di:
    - Risultati della biopsia renale
    - Numero e percentuale dei pazienti con miglioramento relativo rispetto al basale delle manifestazioni cliniche della C3G (proteinuria e ridotta velocit¿ di filtrazione glomerulare stimata [eGFR])
    E.2.2Secondary objectives of the trial
    - To evaluate for improvement in proteinuria following treatment with ACH-0144471 in those patients with significant proteinuria at study entry
    - To evaluate for improvement in eGFR following treatment with ACH-0144471 in those patients with an abnormal eGFR at study entry
    - To evaluate the safety and tolerability of ACH-0144471 in patients with C3G or IC-MPGN by assessing serious adverse events (SAEs), Grade 3 and above adverse events (AEs), Grade 3 and above laboratory abnormalities, and events leading to discontinuation of ACH-0144471
    - Valutare il miglioramento della proteinuria dopo trattamento con ACH-0144471 nei pazienti con proteinuria significativa all¿entrata nello studio
    - Valutare il miglioramento dell¿eGFR dopo trattamento con ACH-0144471 nei pazienti con eGFR anormale all¿entrata nello studio
    - Valutare la sicurezza e la tollerabilit¿ di ACH-0144471 nei pazienti con C3G o IC-MPGN, determinando gli eventi avversi seri (SAE), gli eventi avversi (AE) di grado 3 e superiore, le anomalie di laboratorio di grado 3 e superiore e gli eventi che portano alla sospensione di ACH-0144471
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have completed the C3G Proof of Mechanism (POM) study (ACH471-201) (participation in the long-term follow-up portion of ACH471-201 is not required), OR must meet all the following criteria:
    a. Must have confirmed primary C3G or IC-MPGN as per the following:
    - Initial diagnosis established at least 3 months prior to the first dose of study drug
    - Initial diagnosis prior to the age of 55
    - Not secondary to another underlying condition in the opinion of the PI
    b. Must have confirmation of C3G or IC-MPGN diagnosis with at least 2+ staining for C3c by review of a renal biopsy obtained no more than 30 days (and preferably within 2 weeks) of first dose of study drug by the study’s central pathology laboratory
    c. Must have clinical evidence of ongoing disease based on at least one of the following findings attributable to C3G disease or IC-MPGN in the opinion of the PI, and present prior to study entry and confirmed during Screening:
    - Significant proteinuria, defined as =1 g/day of protein in a 24-hour urine
    - An abnormal eGFR, defined as <=75 mL/min/1.73 m2 (based on CKD-EPI creatinine equation [2009] for patients 19 years old and older, or on “Bedside Schwartz” equation [2009] for patients <19 years old). The abnormal eGFR should not be attributable to non-C3G causes such as angiotensin converting enzyme (ACE) inhibitor use or decreased renal perfusion, in the opinion of the PI
    d. Must have no more than 50% fibrosis and no more than 50% of glomeruli with cellular crescents on the pre-treatment renal biopsy
    e. Must be between the ages of 17 and 65 years, inclusive
    2. If on corticosteroids, anti-hypertensive medications, anti-proteinuric medications (e.g., ACE inhibitors or angiotensin receptor blockers [ARBs]), or mycophenolate mofetil (MMF), must be on a stable dose for at least 4 weeks prior to the first screening visit
    3. Female participants of childbearing potential must agree to use an acceptable method of contraception (as defined in Section 5.5.5) from the date of signing the informed consent to the first day of dosing (Day 1), and must agree to use a highly effective form of contraception (as defined in Section 5.5.5) from the first day of dosing to 30 days after their last dose of study drug. Female participants of childbearing potential must also have a negative serum pregnancy test during Screening and negative urine pregnancy test on Day 1. Female participants of non-childbearing potential need not employ a method of contraception.
    4. Non-sterile male participants must agree to use a highly effective form of contraception (as defined in Section 5.5.5) with their partner(s) of childbearing potential from the first day of dosing to 90 days after their last dose of study drug. Male participants who are surgically sterile need not employ additional contraception. Male participants must agree not to donate sperm while enrolled in this study and for up to 90 days after their last dose of study drug.
    5. Must be capable of providing written informed consent, must be willing and able to comply with the requirements and restrictions listed in the consent form and with all procedures in the protocol
    6. Must be up-to-date on routine vaccinations, or willing to be brought up-to-date, based on local guidelines
    7. Must be willing to comply with study-specific vaccination requirements, including those for N. meningitidis, H. influenzae, and S. pneumoniae
    8. Must be willing to have transportation and telephone access, and to be within one hour of an emergency medical center
    1. Completamento dello studio di prova del meccanismo (Proof of Mechanism, POM) (ACH471-201) (la partecipazione alla parte di follow-up a lungo termine di ACH471-201 non è necessaria), o deve soddisfare tutti i seguenti criteri:
    a. Conferma di C3G o IC-MPGN primaria secondo quanto segue: diagnosi iniziale confermata almeno 3 mesi prima della prima somministrazione del farmaco in studio; diagnosi iniziale prima dell’età di 55 anni; non secondaria a un’altra condizione sottostante secondo la valutazione dello sperimentatore
    b. Conferma della diagnosi di C3G o IC-MPGN con valore di almeno 2+ alla colorazione per C3c all‘esame di una biopsia renale ottenuta non più di 30 giorni (e preferibilmente entro 2 settimane) prima della prima somministrazione del farmaco in studio, effettuata dal laboratorio centrale di patologia dello studio
    c. Evidenza clinica di malattia in corso in base ad almeno uno dei seguenti dati attribuibili alla malattia C3G o IC-MPGN secondo lo sperimentatore, presente prima dell‘ingresso nello studio e confermata durante lo screening: proteinuria significativa, definita come >= 1 g / giorno di proteine nelle urine delle 24 ore; eGFR anormale, definita come <= 75 mL/min/1,73 m2 (in base all‘equazione della creatinina CKD-EPI [2009] per i pazienti di 19 anni e oltre, o all’equazione "Bedside Schwartz" [2009] per i pazienti < 19 anni d‘età). L’eGFR anormale non deve essere attribuibile a cause diverse dalla C3G, quali l’uso degli inibitori dell‘enzima di conversione dell‘angiotensina (ACE) o una diminuita perfusione renale, secondo lo sperimentatore
    d. Non devono presentare più del 50% di fibrosi e più del 50% dei glomeruli con semilune cellulari alla biopsia renale pre-trattamento
    e. Devono avere un‘età compresa tra i 17 e i 65 anni
    2. Se in terapia con corticosteroidi, medicamenti antipertensivi, anti-proteinurici (es. ACE-inibitori o antagonisti dei recettori dell’angiotensina [ARB]) o micofenolato mofetile (MMF), devono essere a un dosaggio stabile da almeno 4 settimane prima della prima visita di screening
    3. Le partecipanti di sesso femminile in età fertile devono essere d’accordo ad utilizzare un metodo di contraccezione accettabile (come definito nella Sezione 5.5.5) dalla data di firma del consenso al primo giorno di dosaggio (giorno 1) e devono accettare di utilizzare l’uso di una forma altamente efficace di contraccezione (come definito nella sezione 5.5.5) dal primo giorno di dosaggio fino a 30 giorni dopo l‘ultima somministrazione di ACH-0144471. I soggetti di sesso femminile in età fertile devono inoltre avere un test di gravidanza negativo sul siero durante lo screening e un test di gravidanza sulle urine negativo al giorno 1. I soggetti di sesso femminile in età non fertile non devono utilizzare alcun tipo di contraccezione.
    4. I partecipanti di sesso maschile devono accettare di utilizzare una forma altamente efficace di contraccezione (come definito nella sezione 5.5.5) con la/e loro partner/s in età fertile dal primo giorno di dosaggio a 90 giorni dopo l‘ultima dose di farmaco sperimentale. Per i partecipanti di sesso maschile sterilizzati chirurgicamente non è necessaria alcuna contraccezione supplementare. I partecipanti di sesso maschile devono accettare di non donare lo sperma durante questo studio e fino a 90 giorni dopo l‘ultima somministrazione di farmaco sperimentale.
    5. Devono essere in grado di fornire il consenso informato scritto
    6. Devono essere in regola con le vaccinazioni di routine o disposti a venir vaccinati in base alle linee guida locali
    7. Devono essere disposti a rispettare i requisiti di vaccinazione specifici dello studio, compresi quelli per N. meningitidis, H. influenzae e S. pneumoniae
    8. Avere accesso ai mezzi di trasporti ed essere raggiungibili telefonicamente e di rimanere alla distanza massima di un‘ora da un pronto soccorso
    E.4Principal exclusion criteria
    1. Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant
    2. Have a history or presence of any clinically relevant co-morbidities that would make the patient inappropriate for the study (for example, a comorbidity which is likely to result in deterioration of the patient’s condition, affect the patient’s safety during the study, or confound the results of the study), in the opinion of the PI
    3. Have an estimated GFR <30 mL/min/1.73 m2 at the time of screening or at any time over the preceding four weeks
    4. Have C4 levels <80% LLN at the time of screening (applicable only to participants who did not complete ACH471-201)
    5. Is a renal transplant recipient or receiving renal replacement therapy
    6. Have other renal diseases that would interfere with interpretation of the study
    7. Have evidence of monoclonal gammopathy of unclear significance (MGUS), infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN may be secondary
    8. Have been diagnosed with or show evidence of hepatobiliary cholestasis
    9. Are known to have Gilbert’s syndrome and/or have a history suggestive of Gilbert’s syndrome
    10. Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration or patients with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration
    11. Have a history of febrile illness, a body temperature >38°C, or other evidence of a clinically significant active infection, within 14 days prior to ACH-0144471 administration
    12. Have evidence of human immunodeficiency virus (HIV) (positive serology for HIV antibody [HIV Ab]), hepatitis B infection (positive hepatitis B surface antigen [HbsAg]), or hepatitis C infection (positive anti-HCV antibody [HCV Ab]) at Screening or historically
    13. Have a history of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
    14. Have a contraindication to one or more of the required vaccinations
    15. Have a history of hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems, which, in the opinion of the investigator and/or an appropriately qualified immunology or infectious disease expert, would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
    16. Have participated in a clinical study in which an investigational drug was given within 30 days, or within 5 half-lives of the investigational drug, whichever is longer, prior to the first dose of ACH-0144471
    17. Have received eculizumab at any dose or interval within the past 75 days prior to the first dose of ACH-0144471
    18. Have received tacrolimus or cyclosporine within 2 weeks of the first dose of ACH-0144471
    19. Have a 12-lead ECG with a QTcF >450 msec for males or >470 msec for females, or have ECG findings which, in the opinion of the PI, could put the patient at undue risk
    20. Have received any drug known to prolong the QTc interval within 2 weeks of the first dose of ACH-0144471
    21. Have any of the following laboratory abnormalities at screening:
    Alanine transaminase (ALT) > upper limit of normal (ULN)
    Aspartate aminotransferase (AST) > ULN
    Absolute neutrophil counts (ANC) <1,000/µL
    Total bilirubin >1.5× ULN
    Indirect bilirubin > ULN
    Any laboratory abnormality that, in the opinion of the PI, would make the patient inappropriate for the study
    1. Storia di un trapianto d‘organo maggiore (es. cuore, polmone, rene, fegato) o trapianto di cellule staminali ematopoietiche/di midollo
    2. Storia o presenza di eventuali comorbidità clinicamente rilevanti che renderebbe il paziente non idoneo per lo studio (ad esempio, una comorbidità che rischia di determinare un deterioramento della condizione del paziente, di pregiudicare la sicurezza del paziente durante lo studio o di confondere i risultati dello studio), secondo il parere dello sperimentatore
    3. GFR stimata <30 mL/min/1,73 m2 al momento dello screening o in qualsiasi momento nelle quattro settimane precedenti
    4. Avere un valore di C4<80% del livello inferiore di normalità al momento dello screening (applicabile solo ai pazienti che non hanno completato lo studio ACH471-201)
    5. Ricevente di trapianto renale o di terapia sostitutiva renale
    6. Altre malattie renali che potrebbero interferire con l‘interpretazione dello studio
    7. Evidenza di gammopatia monoclonale di significato incerto (MGUS), infezioni, lesioni maligne, malattie autoimmuni o altre condizioni rispetto a cui C3G o IC-MPGN potrebbero essere secondarie
    8. Diagnosi o evidenza di colestasi epatobiliare
    9. Sindrome di Gilbert nota e/o storia indicativa di una sindrome di Gilbert
    10. Donne in gravidanza, in allattamento, o che desiderano una gravidanza durante lo studio o entro 90 giorni dalla somministrazione di ACH-0144471 o pazienti con partner di sesso femminile in gravidanza, in allattamento, o che desiderano una gravidanza durante lo studio o entro 90 giorni dalla somministrazione di ACH-0144471
    11. Storia di malattia febbrile, temperatura corporea > 38 °C o altra evidenza di un‘infezione attiva clinicamente significativa, entro i 14 giorni precedenti la somministrazione di ACH-0144471
    12. Storia o evidenza allo screening del virus dell’immunodeficienza umana (HIV) (positività sierologica per l’anticorpo anti-HIV [HIV Ab]), infezione da epatite B (positività per l’antigene di superficie dell‘epatite B [HbsAg]) o infezione da epatite C (positività per gli anticorpi anti-HCV [HCV Ab])
    13. Storia di infezione da meningococchi o contatto con un parente di primo grado o un familiare con storia di infezione da meningococchi
    14. Controindicazione a una o più delle vaccinazioni richieste
    15. Storia di reazioni di ipersensibilità agli agenti antibatterici comunemente usati, tra cui beta-lattamici, penicillina, aminopenicilline, fluorochinoloni, cefalosporine e carbapenemi che, a parere dello sperimentatore e/o di un immunologo o infettivologo esperto, renderebbero difficile fornire la terapia antibiotica empirica o il trattamento di un‘infezione attiva.
    16. Partecipazione a uno studio clinico in cui è stato somministrato un medicamento sperimentale entro 30 giorni o entro 5 emivite del medicamento sperimentale, a seconda del periodo più lungo, prima della prima somministrazione di ACH-0144471
    17. Trattamento con eculizumab a qualsiasi dose o intervallo entro gli ultimi 75 giorni precedenti la prima somministrazione di ACH-0144471
    18. Trattamento con tacrolimus o ciclosporina entro le 2 settimane precedenti la prima somministrazione di ACH-0144471
    19. ECG a 12 derivazioni con un QTcF >450 msec negli uomini e >470 msec nelle donne, o risultati ECG che, secondo lo sperimentatore, potrebbero esporre il paziente a un rischio eccessivo
    20. Trattamento con un qualsiasi medicamento che prolunghi notoriamente l‘intervallo QTc entro le 2 settimane precedenti la prima somministrazione di ACH-0144471
    21. Una qualsiasi delle seguenti anomalie di laboratorio allo screening:
    _ Alanina transaminasi (ALT) > limite superiore della norma (ULN)
    _ Aspartato aminotransferasi (AST) > ULN
    _ Conta assoluta dei neutrofili (ANC) <1.000 µL
    _ Bilirubina totale >1,5× ULN
    _ Bilirubina indiretta > ULN
    _ Qualsiasi anomalia di laboratorio che, a giudizio dello sperimentatore, renderebbe il paziente non idoneo per lo studio
    E.5 End points
    E.5.1Primary end point(s)
    - Change and percent change from baseline in biopsy, based on a score incorporating changes in both the activity index and C3 staining, at the end of 12 months of treatment
    - Number and percent of patients with significant improvement relative to baseline in clinical manifestation(s) of C3G (proteinuria, reduced eGFR, or both) at the end of 12 months of treatment
    - Cambiamenti e variazioni percentuali dal basale alla biopsia, sulla base di un punteggio che incorpora variazioni dell‘indice di attività e della colorazione per C3, alla fine dei 12 mesi di trattamento
    - Numero e percentuale dei pazienti con significativo miglioramento rispetto al basale delle manifestazioni cliniche della C3G (proteinuria, ridotta eGFR o entrambe) alla fine dei 12 mesi di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of 12 months of treatment
    Alla fine dei 12 mesi di trattamento
    E.5.2Secondary end point(s)
    - Change and percent change from baseline in proteinuria over the 12 months of treatment
    - Change and percent change from baseline in eGFR over the 12 months of treatment
    - Cambiamenti e variazioni percentuali rispetto al basale della proteinuria nei 12 mesi di trattamento
    - Cambiamenti e variazioni percentuali rispetto al basale della eGFR nei 12 mesi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the 12 months of treatment
    Durante i 12 mesi di trattamento
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Assessment of biomarkers
    Valutazione di biomarcatori
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.2.3.1Comparator description
    Non applicabile
    Not applicable
    E.8.2.4Number of treatment arms in the trial1
    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 No
    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 EEA5
    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 Information not present in EudraCT
    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
    United States
    Belgium
    Italy
    Netherlands
    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
    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 months9
    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 months8
    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.1.1.1In 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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 9
    F.4.2.2In the whole clinical trial 20
    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)
    After completing the 12 month treatment period, all study subjects will be offered the opportunity to enroll in a extension trial assuming the totality of the efficacy and safety data across the ongoing C3G studies supports this decision.
    In addition the sponsor reserves the right to close any study site or terminate the study at any time for any reason at the sole discretion of the sponsor.
    Dopo il completamento del periodo di 12 mesi di trattamento, a tutti i soggetti arruolati nello studio sar¿ offerta la possibilit¿ di venire inseriti in un studio clinico di estensione, assumendo che la totalit¿ dei dati di efficacia e sicurezza raccolti durante gli studi C3G in corso supportino questa decisione.
    Inoltre il promotore si riserva il diritto di chiudere qualsiasi centro sperimentale o chiudere lo studio in ogni momento per qualsiasi ragione a discrezione del Promotore.
    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 Decision2018-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-26
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