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    Summary
    EudraCT Number:2011-004564-30
    Sponsor's Protocol Code Number:VX11-950-118
    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:2012-10-22
    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 number2011-004564-30
    A.3Full title of the trial
    A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus
    Studio di fase 1/2 in due parti, condotto in aperto, a braccio singolo, per valutare la sicurezza, la farmacocinetica e l’efficacia di telaprevir in combinazione con peginterferone alfa-2b e ribavirina in soggetti pediatrici di età compresa fra 3 e 17 anni, affetti da virus dell’epatite C genotipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Two-Part Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
    Studio in due parti per valutare la sicurezza, la farmacocinetica e l'efficacia di telaprevir in combinazione con peginterferone alfa-2b e ribavirina in soggetti pediatrici affetti da virus dell'epatite C
    A.4.1Sponsor's protocol code numberVX11-950-118
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/127/2008
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVERTEX PHARMACEUTICALS INCOPORATED
    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 supportVertex Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointMedical Information Center
    B.5.3 Address:
    B.5.3.1Street Address130 Waverly Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 617 348 789
    B.5.5Fax numbernot applicable
    B.5.6E-mailmedicalinfo@vrtx.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 nameTelaprevir
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNTelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.9.3Other descriptive nameTELAPREVIR
    D.3.9.4EV Substance CodeSUB31651
    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 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 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 nameTelaprevir
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNTelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.9.3Other descriptive nameTELAPREVIR
    D.3.9.4EV Substance CodeSUB31651
    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 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.2.1.1.1Trade name Incivek
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceutical Incorporated
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 INNTelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.9.4EV Substance CodeSUB31651
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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: 4
    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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, hard
    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.3.9.4EV 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.IMP: 5
    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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Oral solution
    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.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 6
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder and solvent for 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 INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 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) 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: 7
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder and solvent for 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 INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) 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: 8
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder and solvent for 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 INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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) 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 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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder and solvent for 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 INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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
    Genotype 1 Hepatitis C Virus
    Virus dell’epatite C genotipo 1
    E.1.1.1Medical condition in easily understood language
    Genotype 1 Hepatitis C Virus
    Virus dell’epatite C genotipo 1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PART A: - To evaluate the short-term safety of telaprevir in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) (Peg-IFN/RBV) in treatment-naïve pediatric subjects without cirrhosis; - To evaluate the pharmacokinetics (PK) and determine the appropriate dose of telaprevir in combination with Peg-IFN/RBV in treatment-naive pediatric subjects without cirrhosis; PART B: - To evaluate the safety of telaprevir in combination with Peg-IFN/RBV in treatment-naive and peginterferon/RBV treatment-experienced pediatric subjects with or without cirrhosis
    PARTE A: - Valutare la sicurezza a breve termine di telaprevir in combinazione con peginterferone alfa-2b (Peg-IFN) e ribavirina (RBV) (Peg-IFN/RBV) in soggetti pediatrici naïve al trattamento senza cirrosi; - Valutare la farmacocinetica (PK) e determinare la dose appropriata di telaprevir in combinazione con Peg-IFN/RBV in soggetti pediatrici naïve al trattamento senza cirrosi; PARTE B: - Valutare la sicurezza di telaprevir in combinazione con Peg-IFN/RBV in soggetti pediatrici naïve al trattamento e già sottoposti a trattamento con peginterferone/RBV con o senza cirrosi
    E.2.2Secondary objectives of the trial
    PART A: - To evaluate the efficacy of telaprevir in combination with Peg-IFN/RBV in treatment-naive pediatric subjects without cirrhosis; PART B: - To evaluate the efficacy of telaprevir in combination with Peg-IFN/RBV in treatment-naive and peginterferon/RBV treatment-experienced pediatric subjects with or without cirrhosis; - To evaluate the PK of telaprevir in combination with Peg-IFN/RBV in treatment-naive and peginterferon/RBV treatment-experienced pediatric subjects with or without cirrhosis
    PARTE A: - Valutare l’efficacia di telaprevir in combinazione con Peg-IFN/RBV in soggetti pediatrici naïve al trattamento senza cirrosi; PARTE B: - Valutare l’efficacia di telaprevir in combinazione con Peg-IFN/RBV in soggetti pediatrici naïve al trattamento e già sottoposti a trattamento con peginterferone/RBV con o senza cirrosi; - Valutare la PK di telaprevir in combinazione con Peg-IFN/RBV in soggetti pediatrici naïve al trattamento e già sottoposti a trattamento con peginterferone/RBV con o senza cirrosi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females ages 3 to 17 years of age, inclusive, on the date of signed informed consent form (ICF), and where appropriate, date of assent 2. Chronic hepatitis C based on serum antibody or HCV RNA detectable at least twice, at least 6 months apart; measurable HCV RNA in the blood; and evidence of liver inflammation documented by abnormal liver transaminases or by a liver biopsy a. If a liver biopsy is available, it must have been performed within 2 years of screening b. Treatment can be initiated if histopathology shows fibrosis >Stage 0 or inflammation >Grade 0 c. An elevation of ALT within 1 year of screening 3. Hepatitis C virus RNA ≥1000 IU/mL at the Screening Visit 4. Hepatitis C virus genotype 1a or b at the Screening Visit 5. One of the following: a. Hepatitis C virus treatment-naive subjects may not have received any previous treatment, experimental or approved, for hepatitis C (Part A and Part B). b. Peginterferon/RBV prior relapse (Documented undetectable HCV RNA level at the planned EOT of at least 42-week duration [HCV RNA evaluated within 6 weeks after the last dose of medication] but did not achieve SVR24. Start and stop dates of treatment must be documented. The last dose of peginterferon/RBV must have been at least 12 weeks before the Screening Visit.) (Part B only). c. Peginterferon/RBV prior null responder (Part B only): - Failure to decrease HCV RNA by <2 logs after at least 12 weeks of therapy. For documentation of prior treatment experience Week 12 response, a Week 11 to 24 window is allowed. d. Peginterferon/RBV prior partial responder (Part B only): - Had a ≥2 log decrease in HCV RNA at Week 12 but never achieved undetectable HCV RNA while on treatment (partial responder). For documentation of prior treatment experience Week 12 response, a Week 11 to 24 window is allowed. Subjects must have received the last dose of peginterferon/RBV at least 12 weeks before the Screening Visit. The following information related to the virologic response to the last course of peginterferon/RBV must be available in the medical records of the subject: - Start and end date of the previous treatment course - Hepatitis C virus RNA results before the start of treatment (all subjects), after at least 12 weeks of treatment (null and partial responders), at EOT (all subjects), and during follow-up (relapsers). The most recent HCV RNA value obtained within 6 months before the start of prior treatment is to be used as the baseline. 6. Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator, on the basis of medical history and physical examination (including vital signs and screening ECG), with any chronic medical conditions under stable medical control 7. Female subjects of childbearing potential must agree to either remain abstinent or to use 2 effective methods of contraception from at least 14 days before first dose of study drug through 6 months after the last dose of RBV. Male subjects who have a female partner of childbearing potential must agree to either remain abstinent or to use 2 effective methods of contraception from Day 1 through 7 months after the last dose of RBV. 8. Signed ICF, and where appropriate, signed Assent Form 9. Able to refrain from concomitant use of any medications, substances, or foods as described in the Study Protocol.
    1. Soggetti di entrambi i sessi e di età compresa tra 3 e 17 anni (inclusi) al momento della firma del modulo di consenso informato (ICF) o dell’assenso, a seconda dei casi. 2. Quadro di epatite C cronica confermato da livelli sierici rilevabili di anticorpi anti-HCV o HCV RNA in almeno 2 occasioni a distanza di almeno 6 mesi; livelli misurabili di HCV RNA nel sangue; ed evidenze di infiammazione epatica documentata da livelli anomali di transaminasi epatiche o da una biopsia epatica. a. Per essere ritenuta valida ai fini dello studio, la biopsia epatica deve essere stata effettuata nei 2 anni precedenti lo screening. b. Il trattamento può essere iniziato se gli esami istopatologici evidenziano una fibrosi a uno stadio &gt;0 o un’infiammazione di grado &gt;0. c. Nell’anno precedente lo screening il soggetto deve aver presentato un innalzamento dei valori di ALT. 3. HCV RNA ≥1.000 IU/mL alla Visita di screening. 4. Virus dell’epatite C di genotipo 1a o 1b alla Visita di screening. 5. Uno dei seguenti: a. i soggetti infettati con il virus dell’epatite C naïve al trattamento possono non aver ricevuto trattamenti precedenti (approvati o sperimentali) per l’epatite C (Parte A e Parte B); b. soggetti con precedente recidiva in seguito al trattamento con peginterferone/RBV (livelli non rilevabili di HCV RNA documentati alla visita EOT programmata e perduranti per almeno 42 settimane [valutazione dei livelli di HCV RNA entro 6 settimane dall’ultima dose del farmaco] ma mancato raggiungimento della SVR24. Devono essere indicate le date di inizio e di fine trattamento. L’ultima dose di peginterferone/RBV deve essere stata somministrata almeno 12 settimane prima della Visita di screening (solo parte B); c. soggetti con precedente risposta nulla a peginterferone/RBV (solo Parte B): - impossibilità di ridurre i livelli di HCV RNA di &lt;2 log dopo almeno 12 settimane di terapia. Per documentare la risposta alla Settimana 12 a un precedente trattamento è possibile considerare una finestra temporale tra la Settimana 11 e la Settimana 24; d. soggetti con precedente risposta parziale a peginterferone/RBV (solo Parte B): - hanno mostrato una riduzione nei livelli di HCV RNA ≥2 log alla Settimana 12 ma non hanno mai raggiunto livelli non rilevabili di HCV RNA durante il trattamento (“partial responder”). Per documentare la risposta alla Settimana 12 a un precedente trattamento è possibile considerare una finestra temporale tra la Settimana 11 e la Settimana 24. I soggetti devono aver ricevuto l’ultima dose di peginterferone/RBV almeno 12 settimane prima della Visita di screening. Le seguenti informazioni relative alla risposta virologica all’ultimo ciclo di peginterferone/RBV devono essere presenti nella cartella clinica del soggetto: - data di inizio e di fine del ciclo di trattamento precedente; - livelli di HCV RNA prima dell’inizio del trattamento (tutti i soggetti), dopo almeno 12 settimane di trattamento (soggetti con risposta nulla e parziale), alla visita EOT (tutti i soggetti) e durante il follow-up (soggetti recidivanti). Il valore di HCV RNA più recente ottenuto nei 6 mesi antecedenti l’inizio del trattamento precedente deve essere usato come valore basale. 6. Soggetti considerati in buona salute (a parte l’infezione da HCV) secondo il giudizio dello sperimentatore, in base alla storia medica e all’esame obiettivo (con misurazione dei segni vitali e l’esecuzione di un ECG allo screening) e le cui eventuali patologie croniche siano stabili e sotto controllo. 7. I soggetti di sesso femminile in età fertile devono acconsentire a praticare l’astinenza o a utilizzare 2 metodi contraccettivi efficaci a partire da almeno 14 giorni precedenti la prima dose di farmaco in studio fino a 6 mesi dopo l’ultima dose di RBV. I soggetti di sesso maschile con partner in età fertile devono acconsentire a praticare l’astinenza...[si veda il protocollo di studio]
    E.4Principal exclusion criteria
    1. History of or prior evidence of a medical condition associated with chronic liver disease other than HCV, including, but not limited to, hepatitis B, abnormal ceruloplasmin, alpha-1-antitrypsin, ANA >1:640, smooth muscle antibody >1:80, anti-liver/kidney microsomal antibody >60 units, hepatic malignancy or malignancy with prior hepatic involvement, drug- or alcohol-related hepatitis or cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and clinically significant steatosis 2. Body weight <15 kg or >90 kg 3. Prior evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices and/or laboratory results as indicated in the Study Protocol 4. Clinical suspicion in the opinion of the investigator for pubertal growth spurt and risk for growth delay that may outweigh the benefit of HCV treatment, to be assessed on a case by case basis as described in the Peg-IFN EU SmPC 5. Serum alfa-fetoprotein (AFP) ≥10 ng/mL at the Screening Visit or clinical suspicion of hepatocellular carcinoma. 6. Positive test at the Screening Visit for HBV DNA, anti-HAV immunoglobulin M antibody, or anti-HIV antibody 7. Screening laboratory values as listed in the Study Protocol 8. Contraindications to Peg-IFN/RBV 9. History of congenital QT prolongation or family history of congenital QT prolongation or sudden death 10. History of autoimmune or immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) 11. Active malignant disease or history of malignant disease (except for subjects in complete remission for >5 years from leukemia) 12. History of a chronic medical condition that in the opinion of the investigator may preclude study participation 13. Major depression according to the CDI 2TM or a history of severe psychiatric disorder, such as major psychoses, severe anxiety or personality disorder, suicidal ideation and/or suicide attempt, or any psychiatric condition that in the opinion of the investigator would preclude study participation (Subjects newly identified to have major depression by the CDI 2TM should be referred to a mental health clinic or specialist.) 14. History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation 15. History of craniocerebral trauma that in the opinion of the investigator could lead to a lower threshold for seizure or active seizure disorder requiring medication 16. History of organ transplant (except cornea or skin) 17. Medical condition that requires frequent or prolonged use of systemic corticosteroids (e.g., severe asthma or autoimmune conditions) 18. History or other evidence of severe retinopathy or clinically significant ophthalmological disorder including, but not limited to, disease due to diabetes mellitus or hypertension. For subjects with a history of hypertension or diabetes, fundoscopic examination within the Screening Period by a physician or documented within 60 days of Day 1 is required to exclude baseline retinopathy. 19. History of intercurrent illness (e.g., upper respiratory illness with fever) within 5 days before the first dose of study drug 20. History of non-genotype 1 HCV 21. Currently using drugs (illicit drugs or controlled narcotics) or alcohol. A urine screen positive for drugs of abuse as described in the Study Protocol except for subjects with positive drug screen for opiates, cannabinoids, benzodiazepines, or tricyclic antidepressants for which the investigator deems these not be to drugs of abuse. 22. History of recent drug or alcohol abuse that would, in the opinion of the investigator, limit adherence or compliance to the study...[please see the protocol]
    1. Storia o evidenze precedenti di una patologia associata a epatopatia cronica diversa da HCV, inclusi, a titolo puramente esemplificativo, epatite B, livelli anomali di ceruloplasmina, alfa-1-antitripsina, ANA &gt;1:640, anticorpi anti-muscolo liscio &gt;1:80, anticorpi anti-microsomi epatici e renali &gt;60 unità, neoplasia maligna a carico del fegato o con precedente interessamento epatico, epatite o cirrosi correlata all’abuso di alcol o sostanze, epatite autoimmune, emocromatosi, malattia di Wilson e steatosi epatica clinicamente significativa. 2. Peso corporeo &lt;15 kg o &gt;90 kg. 3. Precedenti evidenze di scompenso epatico: storia di ascite, encefalopatia epatica o varici esofagee sanguinanti e/o valori degli esami di laboratorio come indicato nel Protocollo di studio. 4. Sospetto clinico, nell’opinione dello sperimentatore, di uno scatto di crescita puberale e rischio di un ritardo della crescita che potrebbe neutralizzare i benefici del trattamento dell’HCV, da valutare caso per caso come descritto nell’RCP UE di Peg-IFN. 5. Livelli sierici di alfa-fetoproteina (AFP) ≥10 ng/mL alla Visita di screening o sospetto clinico di carcinoma epatocellulare. 6. Positività, alla Visita di screening, al test per l’HBV DNA, l’anticorpo anti-HAV (IgM) o l’anticorpo anti-HIV. 7. Risultati agli esami di laboratorio effettuati allo screening come indicati nel Protocollo di studio. 8. Controindicazioni a Peg-IFN/RBV. 9. Storia di prolungamento congenito del tratto QT o anamnesi familiare di prolungamento congenito del tratto QT o morte improvvisa. 10. Storia di malattia autoimmune o immunomediata (p.es. malattia infiammatoria intestinale, porpora trombocitopenica idiopatica, lupus eritematoso sistemico, anemia emolitica autoimmune, sclerodermia, psoriasi grave, artrite reumatoide). 11. Neoplasia maligna attiva o storia di neoplasia maligna (tranne i soggetti ex-leucemici in remissione completa da &gt;5 anni). 12. Storia di una malattia cronica che, nell’opinione dello sperimentatore, potrebbe precludere la partecipazione allo studio. 13. Depressione maggiore in base al test CDI 2TM o storia di malattia psichiatrica grave come psicosi maggiore, grave disturbo ansioso o della personalità, ideazione suicidaria e/o tentativo suicidario, o qualsiasi disturbo psichiatrico che, nell’opinione dello sperimentatore, precluderebbe la partecipazione allo studio (i soggetti con diagnosi recente di depressione maggiore secondo il CDI 2TM devono essere indirizzati a un centro o a uno specialista di salute mentale). 14. Storia o altre evidenze di malattia polmonare o cardiaca cronica associata a una limitazione funzionale. 15. Precedente trauma cranio-encefalico che, nell’opinione dello sperimentatore, potrebbe abbassare la soglia delle convulsioni o scatenare un disturbo convulsivo attivo richiedendo un trattamento farmacologico. 16. Precedente trapianto d’organo (tranne cornea o impianto cutaneo). 17. Malattia che richiede l’uso frequente o prolungato di corticosteroidi sistemici (p.es. asma grave o malattie autoimmuni). 18. Storia o altre evidenze di retinopatia grave o disturbo oftalmologico clinicamente significativo inclusi, a titolo puramente esemplificativo, quelli correlati a diabete mellito o ipertensione. I soggetti affetti da ipertensione o diabete devono essere sottoposti a un esame del fondo oculare durante il Periodo di screening o devono disporre del risultato di tale esame effettuato nei 60 giorni precedenti il Giorno 1 per escludere una retinopatia al basale. 19. Malattia intercorrente (p.es. malattia delle vie aeree superiori accompagnata da febbre) nei 5 giorni precedenti la prima dose di farmaco in studio. 20. Storia di HCV di genotipo diverso dal tipo 1. 21. Uso corrente di sostanze (illecite o soggette a controllo) o alcol. Esame delle urine positivo alla presenza di sostanze d’abuso...[si veda il Protocollo di studio]
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters, including AEs, study drug modifications or discontinuations, clinical laboratory values, vital signs, and electrocardiogram (ECG) assessments
    Parametri di sicurezza, inclusi eventi avversi (AE), modifiche o sospensioni dei farmaci in studio, risultati degli esami di laboratorio, segni vitali e valutazioni ECG (elettrocardiogramma)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 52 weeks
    Fino alla settimana 52
    E.5.2Secondary end point(s)
    - Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (SVR12) - Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) - Proportion of subjects who achieve undetectable HCV RNA at Week 4, at Week 12, at both Weeks 4 and 12 (eRVR), and at the planned end of treatment (EOT) - Proportion of subjects with on-treatment virologic failure, defined as either meeting a futility rule or completing the assigned treatment duration with detectable HCV RNA at the EOT - Proportion of subjects with virological relapse, defined as having undetectable HCV RNA at planned EOT followed by detectable HCV RNA after planned EOT - Part A only: PK of telaprevir (including maximum observed plasma concentration [Cmax], time to maximum plasma concentration [tmax], area under the plasma concentration versus time curve [AUC], and elimination half-life [t1/2]) - Changes from baseline in the amino acid sequence of the HCV NS3•4A protease
    - Percentuale di soggetti che raggiungono una risposta virologica sostenuta (SVR), ovvero livelli non rilevabili di HCV (virus dell’epatite c) RNA, 12 settimane dopo l’ultima dose prevista di farmaco in studio (SVR12)- Percentuale di soggetti che raggiungono la SVR (HCV RNA non rilevabile) 24 settimane dopo l’ultima dose prevista di farmaco in studio (SVR24) - Percentuale di soggetti che raggiungono la SVR (HCV RNA non rilevabile) alla Settimana 4, alla Settimana 12, sia alla Settimana 4 sia alla Settimana 12 (risposta virologica rapida estesa [eRVR]) e al termine previsto del trattamento (EOT) - Percentuale di soggetti che presentano fallimento virologico durante il trattamento, definiti come soggetti che soddisfano una regola di futilità o che al termine del periodo di trattamento previsto (EOT) presentano livelli rilevabili di HCV RNA  Percentuale di soggetti con recidiva virologica, definiti come soggetti che non presentano livelli rilevabili di HCV RNA alla EOT prevista i quali successivamente tornano rilevabili  Solo per la Parte A: PK di telaprevir (inclusi concentrazione plasmatica massima osservata, tempo alla concentrazione plasmatica massima, area sotto la curva di concentrazione/tempo (AUC) ed emivita di eliminazione) - Variazioni rispetto al basale nella sequenza di amminoacidi della proteasi NS3/4A dell’HCV
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 52 weeks
    Fino alla settimana 52
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient 5 Years (±1 month) extended follow-up visit after last dose of study drugs
    Visita di Follow-up di lungo periodo: 5 anni (+ o – 1 mese) dopo l’ultima somministrazione di farmaco per l’ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months73
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months73
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    When patients end their participation in the trial, they will be treated as clinically indicated by the investigator or referring physician after discussion of available options.
    Quando i pazienti termineranno la loro partecipazione allo studio clinico, riceveranno le cure cliniche indicate dallo sperimentatore o dal medico di riferimento dopo avere discusso con loro le opzioni disponibili.
    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 Decision2013-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-07
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