Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-003671-60
    Sponsor's Protocol Code Number:NO-CUT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003671-60
    A.3Full title of the trial
    TOTAL NEOADJUVANT TREATMENT WITHOUT SURGERY FOR LOCALLY ADVANCED RECTAL CANCER: PROSPECTIVE CLINICAL TRIAL TO ASSESS TUMOR COMPLETE RESPONSE, CIRCULATING TUMOR GENETIC AND EPIGENETIC BIOMARKERS, AND STROMAL TRANSCRIPTOME TO INTERPRET CLINICAL OUTCOME (NO-CUT TRIAL)
    TRATTAMENTO NEOADIUVANTE TOTALE SENZA CHIRURGIA PER IL CARCINOMA DEL RETTO LOCALMENTE AVANZATO: STUDIO CLINICO PROSPETTICO PER VALUTARE LA RISPOSTA TUMORALE COMPLETA, BIOMARCATORI CIRCOLANTI TUMORALI GENETICI ED EPIGENETI, E TRASCRIPTOMA STROMALE PER INTERPRETARE IL RISULTATO CLINICO (studio NO-CUT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TOTAL NEOADJUVANT TREATMENT WITHOUT SURGERY FOR LOCALLY ADVANCED RECTAL CANCER: PROSPECTIVE CLINICAL TRIAL TO ASSESS TUMOR COMPLETE RESPONSE, CIRCULATING TUMOR GENETIC AND EPIGENETIC BIOMARKERS, AND STROMAL TRANSCRIPTOME TO INTERPRET CLINICAL OUTCOME (NO-CUT TRIAL)
    TRATTAMENTO NEOADIUVANTE TOTALE SENZA CHIRURGIA PER IL CARCINOMA DEL RETTO LOCALMENTE AVANZATO: STUDIO CLINICO PROSPETTICO PER VALUTARE LA RISPOSTA TUMORALE COMPLETA, BIOMARCATORI CIRCOLANTI TUMORALI GENETICI ED EPIGENETI, E TRASCRIPTOMA STROMALE PER INTERPRETARE IL RISULTATO CLINICO (studio NO-CUT)
    A.3.2Name or abbreviated title of the trial where available
    NO-CUT
    NO-CUT
    A.4.1Sponsor's protocol code numberNO-CUT
    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 SponsorAZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
    B.1.3.4CountryItaly
    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 supportFondazione Oncologia Niguarda Onlus
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAssociazione Italiana per la Ricerca sul Cancro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST Grande Ospedale Metropolitano Niguarda
    B.5.2Functional name of contact pointS.C. Oncologia Medica Falck
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Ospedale Maggiore, 3
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20162
    B.5.3.4CountryItaly
    B.5.4Telephone number0264443695
    B.5.5Fax number0264442957
    B.5.6E-mailsalvatore.siena@ospedaleniguarda.it
    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 OXALIPLATINO KABI - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI ONCOLOGY PLC
    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 nameOxaliplatino
    D.3.2Product code Oxaliplatino
    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 INNOXALIPLATINO
    D.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor codeOxaliplatino
    D.3.9.3Other descriptive nameOxaliplatin
    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 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 Yes
    D.2.1.1.1Trade name CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE 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 nameCapecitabina
    D.3.2Product code Capecitabina
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINA
    D.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeCapecitabina
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Adenocarcinoma of the medium/lower rectum in Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2)
    Adenocarcinoma del retto medio/basso in stadio II (cT3-4 N0) o III (cT1-4, N1-2)
    E.1.1.1Medical condition in easily understood language
    Tumor of the medium/lower rectal intestine in Stage II or Stage III
    Tumore dell'intestino retto medio/basso in stadio II o III
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052360
    E.1.2Term Colorectal adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if the risk of distant relapse in patients managed with Induction ChemoTherapy (ICT) and Chemo-RadioTherapy (CRT) followed by NOM and intensive follow-up is clinically acceptable
    Valutare il tasso di sopravvivenza senza comparsa di metastasi a distanza (distant relapse-free survival, DRFS) a 2,5 anni in pazienti gestiti con chemioterapia di induzione e chemio-radioterapia seguite da non-operative management (NOM) e follow-up intensivo.
    E.2.2Secondary objectives of the trial
    - To assess whether the anticipation of standard adjuvant oxaliplatin-based chemotherapy prior to CRT increases the rate of clinical complete responses;
    - To assess the Local Recurrence (LR) rate, organ (rectum) preservation rate, and colostomy-free survival;
    - To assess Overall Survival (OS);
    - To assess the outcome of NOM in terms of patient-reported outcome measures [PROM]
    Translational Objectives,
    To determine association of:
    - 6-methylated gene panel (6-MGP) in liquid biopsy with local a/o relapse free survival;
    - ctDNA in liquid biopsy with local a/o relapse free survival;
    - stromal score in baseline tumor tissue biopsy with local response
    - Valutare se l¿anticipazione di chemioterapia prima di CRT aumenti il tasso di risposte cliniche complete;
    - Valutare il tasso di recidiva locale (LR), il tasso di conservazione dell'organo (retto) e la sopravvivenza libera da colostomia;
    - Valutare la sopravvivenza complessiva (OS);
    - Valutare l'esito della strategia NOM rispetto alla chirurgia standard in termini di patient reported outcome [PROM]
    Obiettivi Traslazionali,
    determinare l'associazione di:
    -pannello di geni metilati tumore-specifici (6-MGP) mediante biopsia liquida con sopravvivenza libera da recidive locali o a distanza;
    - DNA tumorale circolante (ctDNA) da biopsia liquida con sopravvivenza libera da recidive locali o a distanza;
    - stromal score nella biopsia del tessuto tumorale basale con risposta obiettiva locale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of adenocarcinoma of the medium/lower rectum;
    - Patients must have Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2) tumor;
    - Locally advanced rectal cancer amenable to Total Mesorectal Excision (TME)/Abdominal-Perineal Amputation;
    - No evidence of distant metastases by chest, abdomen, and pelvis contrast enhanced CT scan (TC-PET WB is acceptable alternative in patient allergic to iodate contrast medium);
    - No prior pelvic radiation therapy;
    - No prior oncologic medical therapy or surgery for rectal cancer;
    - Age >18 years;
    - No infections requiring systemic antibiotic treatment;
    - Performance status 0-1 (ECOG Scale);
    - ANC > 1,5 cell/mm3, Hb > 8,0 g/dL, PLT > 150,000/mm3, total bilirubin or equal or 1,5 x upper limit of normal, AST < or equal to three times upper limit of normal, ALT < or equal to three times upper limit of normal; serum creatinine < or equal to 1,5 times the upper limit of normal;
    - Patients must read, agree to, and sign a statement of Informed Consent prior to participation;
    - Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive methods;
    - Male subjects must also agree to use effective contraception
    - Diagnosi istologicamente confermata di adenocarcinoma del retto medio/basso;
    - Tumore in stadio II (cT3-4 N0) o III (cT1-4, N1-2);
    - Tumore rettale localmente avanzato per cui sia possibile total mesorectal excision (TME) / amputazione addomino-perineale;
    - Assenza di metastasi distanti mediante TC del torace-addome-pelvi (la TCPET WB è un’alternativa accettabile in pazienti allergici al mezzo di contrasto
    iodato);
    - Nessuna precedente radioterapia pelvica;
    - Nessuna precedente terapia medica oncologica o chirurgia per il cancro rettale;
    - Età > 18 anni;
    - Nessuna infezione che richiede un trattamento antibiotico sistemico;
    - Performance status 0-1 (scala ECOG);
    - ANC > 1,5 cellule mm3, Hb > 8,0 g/dL, PLT > 150,000/mm3, bilirubina totale <= 1,5 limiti superiori al normale, AST <= tre volte al limite superiore della norma, ALT <= tre volte al limite superiore della norma; livello creatinina <= 1,5 volte al limite superiore della norma;
    - I pazienti devono leggere, accettare e firmare una dichiarazione di consenso informato prima della partecipazione;
    - Le donne con potenziale riproduttivo devono risultare negative per il test di gravidanza (urina, sangue) e accettare l’adozione di metodi contraccettivi efficaci;
    - I soggetti maschi devono accettare di utilizzare una efficace contraccezione
    E.4Principal exclusion criteria
    - Recurrent rectal cancer;
    - Patients with a history of any arterial thrombotic event within the past 6 months, including angina (stable or unstable), MI, or CVA;
    - Intolerance or contraindication to MR procedure;
    - Patients with any other concurrent medical or psychiatric condition that are unstable or could jeopardize the safety of the patient and his/her compliance in the study;
    - Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption;
    - Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer;
    - Patients with a history of thrombotic episodes, such as deep venous thrombosis, pulmonary embolus, MI, or CVA occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy;
    - Patients receiving other anticancer or experimental therapy.
    - Cancro rettale recidivato;
    - Pazienti con anamnesi di qualsiasi evento trombotico arterioso negli ultimi 6 mesi, compresa l'angina (stabile o instabile), infarto del miocardio o CVA;
    - Pazienti con qualsiasi altra condizione medica o psichiatrica concomitante, che sono instabili o potrebbero mettere a repentaglio la sicurezza del paziente e la sua aderenza allo studio;
    - Anomalie gastrointestinali, incapacità di assumere farmaci orali, qualsiasi condizione che influenzi l'assorbimento di farmaci;
    - Precedente tumore maligno negli ultimi 5 anni, ad eccezione del tumore della cute basocellulare o squamocellulare trattati adeguatamente o del cancro della cervice uterina in situ.
    - I pazienti con anamnesi di episodi trombotici, quali trombosi venosa profonda, embolia polmonare, infarto del miocardio o CVA che si sono verificati più di 6 mesi prima dello screening, possono essere considerati per ‘arruolamento nel protocollo, purché siano in dosi stabili di terapia anticoagulante. Possono partecipare anche pazienti che sono in terapia anticoagulante per fibrillazione atriale o altre condizioni, a condizione che siano in dosi stabili di terapia anticoagulante;
    - Pazienti che ricevono altre terapie antitumorali o sperimentali.
    E.5 End points
    E.5.1Primary end point(s)
    Distant Relapse-Free Survival (DRFS) rate at 2.5 year
    Tasso di sopravvivenza libera da recidiva a distanza (distant relapse-free survival, DRFS) a 2,5 anni
    E.5.1.1Timepoint(s) of evaluation of this end point
    2,5 years
    2,5 anni
    E.5.2Secondary end point(s)
    Clinical complete response rate; Local recurrence and organ preservation rate, colostomy-free survival; Overall survival; Patient reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 and its colorectal cancer specific module QLQ-38)
    Tasso di risposta clinica completa; Tasso di recidiva locale, tasso di preservazione d¿organo (retto) e sopravvivenza libera da posizionamento di colostomia; Sopravvivenza complessiva (overall survival); Patient reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 and its colorectal cancer specific module QLQ-38)
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years; 5 years; 5 years; 5 years
    5 anni; 5 anni; 5 anni; 5 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Confronto con dati di letteratura riguardanti tasso di recidive a distanza a 2.5 anni.
    Comparison with literature data concerning recurrence rates at 2.5 years.
    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 concerned3
    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 Information not present in EudraCT
    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
    N.A.
    N.A.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    N.A.
    N.A.
    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 Decision2018-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 19 03:06:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA