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    Summary
    EudraCT Number:2011-005540-99
    Sponsor's Protocol Code Number:AGMT_HNO2
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-005540-99
    A.3Full title of the trial
    Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neck
    Randomisierte Phase II Pilot Studie: Induktionstherapie mit Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU gefolgt von Radioimmuntherapie mit Cetuximab bei lokal fortgeschrittenen oder inoperablen HNO Tumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neck
    Randomisierte Phase II Pilot Studie: Induktionstherapie mit Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU gefolgt von Radioimmuntherapie mit Cetuximab bei lokal fortgeschrittenen oder inoperablen HNO Tumoren
    A.3.2Name or abbreviated title of the trial where available
    AGMT_HNO2
    A.4.1Sponsor's protocol code numberAGMT_HNO2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01884259
    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 SponsorAGMT – Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGMT gemeinnützige GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressWolfsgartenweg 31
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number+436649688870
    B.5.5Fax number+436626404414
    B.5.6E-mailj.schuster@agmt.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erbitux®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCetuximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocetaxel
    D.3.9.2Current sponsor codeAGMT HNO-2
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCispaltin
    D.3.9.2Current sponsor codeAGMT HNO-2
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 name5 Fluorouracil
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or not resectable Carcinoma of the Head and Neck
    Lokal fortgeschrittene oder inoperable HNO Tumore
    E.1.1.1Medical condition in easily understood language
    Locally advanced or not resectable Carcinoma of the Head and Neck
    Lokal fortgeschrittene oder inoperable HNO Tumore
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041862
    E.1.2Term Squamous cell carcinoma of the oral cavity stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041863
    E.1.2Term Squamous cell carcinoma of the oral cavity stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041855
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023860
    E.1.2Term Laryngeal squamous cell carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041854
    E.1.2Term Squamous cell carcinoma of the hypopharynx stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023861
    E.1.2Term Laryngeal squamous cell carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Response Rate (CR, PR) 3 months after end of therapy (RECIST)
    Ansprechrate (CR, PR) 3 Monate nach Beendigung der Therapie (Kriterien nach RECIST)
    E.2.2Secondary objectives of the trial
    Overall Pesponse Rate (CR, PR, PD, SD) (RECIST)
    Locoregionally monitoring after one year
    Progression Free Survival (PFS) and Overall-Survival 1, 2 and 5 years after start of therapy
    Toxicity:
    - Acute toxicity within 3 months after end of radiotherapy
    - Late toxicity: till 60 months after end of radiotherapy
    Ansprechrate der gesamten Therapie (CR, PR, PD, SD) (Kriterien nach RECIST)
    Lokoregionäre Kontrolle nach 1 Jahr (Definition lt. Bonner)
    Progessionsfreies Überleben (PFS) und das Overall-Survival 1, 2 bzw. 5 Jahre nach Studienbeginn:
    - Nachweis einer Tumorprogression (lokoregionär oder distant) oder bis zum Tod (unabhängig von der Ursache)
    - OS ist die Zeit von Studienbeginn bis zum Tod unabhängig von der Ursache
    Toxizität
    - Akuttoxizität: bis 3 Monate nach Radiotherapienende
    - Spättoxizität: bis 60 Monate nach Radiotherapieende
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
    One measureable lesion (CT oder MR)
    Age 18 – 75 (including)
    Performance Score ECOG 0 – 1
    Histologisch bestätigtes, lokal fortgeschrittenes Plattenepithelcarcinom des Larynx, Hypopharynx, Oropharynx oder der Mundhöhle im Stadium III und IV
    In zumindest einer Ebene messbare Läsion (CT oder MR, das gewählte Verfahren muss beibehalten werden)
    Alte 18-75 (eingeschlossen)
    Performance Score ECOG 0 - 1
    E.4Principal exclusion criteria
    Distant metastases
    ECOG Score >1
    Prior radiation (Head and neck area)
    Creatinin Clearance below 60 ml/µl
    Acute infections
    Neuropathy grade 3 or 4
    Myocardial Infarction within the last 12 months
    Acute coronary syndrom or othe clinically significant cardiovascular diseases
    Fernmetastasen
    ECOG Score >1
    Alter unter 18 oder über 75 Jahre
    Geplante oder erfolgte operative Versorgung (mit Ausnahme einer Operation zur Entnahme einer Biopsie oder Anlegen einer Tracheostomie zur Aufrechterhaltung der Atemwege)
    Vorangegangene Bestrahlung im HNO-Bereich
    Adequate Laborparameter
    Creatinin-Clearance unter 60 mL/min
    Akute Infektionen
    Myocardinfarkt in den letzten 12 Monaten vor Einschluss in die Studie
    Akutes Konorarsyndrom (z.B. instabile Angina pectoris) oder andere klinisch signifikante Herz-Kreislauf-Erkrankungen
    Klinisch signifikante Rhythmusstörungen und Myokardiopathie
    Neuropathie Grad 3 oder 4
    Neoplastische Vor- oder Begleiterkrankung ausgenommen Basaliom/Spinaliom der Haut oder Cervixcarcinom in frühem Stadium
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate (CR, PR) 3 months after end of therapy (RECIST)
    Ansprechrate (CR, PR) 3 Monate nach Beendigung der Therapie (Kriterien nach RECIST)
    E.5.1.1Timepoint(s) of evaluation of this end point
    „Last patient in“ expected in June 2014,
    3 months after end of therapy - “Last patient out” (therapy) expectet in December 2014
    „Last patient in“ vorraussichtlich Juni 2014,
    Monate nach Beendigung der Therapie - “Last patient out” (Therapie) vorraussichtlich Dezember 2014
    E.5.2Secondary end point(s)
    Overall Pesponse Rate (CR, PR, PD, SD) (RECIST)
    Locoregionally monitoring after one year
    Progression Free Survival (PFS) and Overall-Survival 1, 2 and 5 years after start of therapy
    Toxicity:
    - Acute toxicity within 3 months after end of radiotherapy
    - Late toxicity: till 60 months after end of radiotherapy
    Ansprechrate der gesamten Therapie (CR, PR, PD, SD) (Kriterien nach RECIST)
    Lokoregionäre Kontrolle nach 1 Jahr (Definition lt. Bonner)
    Progessionsfreies Überleben (PFS) und das Overall-Survival 1, 2 bzw. 5 Jahre nach Studienbeginn:
    - Nachweis einer Tumorprogression (lokoregionär oder distant) oder bis zum Tod (unabhängig von der Ursache)
    - OS ist die Zeit von Studienbeginn bis zum Tod unabhängig von der Ursache
    Toxizität
    - Akuttoxizität: bis 3 Monate nach Radiotherapienende
    - Spättoxizität: bis 60 Monate nach Radiotherapieende
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study: LPLV 60 months after start of therapy of last patient (anticipated June 2019)
    Die Studie endet mit einer Nachbeobachtungsdauer von 60 Monaten bezogen auf den Studienbeginn des einzelnen Patienten (LPLV: 60 Monate nach Einbringung des letzten Patienten - „Last patient in“ vorraussichtlich Juni 2014). “Last patient out” (Nachsorge) vorraussichtlich Juni 2019.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 Yes
    E.8.1.7.1Other trial design description
    Standard therapy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study: LPLV 60 months after start of therapy of last patient (anticipated June 2019)
    Die Studie endet mit einer Nachbeobachtungsdauer von 60
    Monaten bezogen auf den Studienbeginn des einzelnen
    Patienten (LPLV: 60 Monate nach Einbringung des letzten
    Patienten - vorraussichtlich Juni 2019).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    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)
    No. Patients will be followed-up for 5 years (or until trial team decides
    to stop collecting further follow-up data).
    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 Decision2013-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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