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    Summary
    EudraCT Number:2016-003403-66
    Sponsor's Protocol Code Number:1199.225
    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:2021-06-14
    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 number2016-003403-66
    A.3Full title of the trial
    An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)
    Uno studio di estensione in aperto per valutare la sicurezza a lungo termine di nintedanib in pazienti con Malattia Interstiziale del Polmone associata a Sclerosi Sistemica (SSc-ILD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the safety of long term treatment with
    nintedanib in patients with scleroderma related lung fibrosis.
    Studio per valutare la sicurezza a lungo termine di nintedanib in pazienti con Malattia Interstiziale del Polmone associata a Sclerosi Sistemica
    A.3.2Name or abbreviated title of the trial where available
    SENSCIS(TM)- ON
    SENSCIS(TM)- ON
    A.4.1Sponsor's protocol code number1199.225
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorBOEHRINGER-INGELHEIM ITALIA S.P.A.
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringeringelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1724
    D.3 Description of the IMP
    D.3.1Product nameNintedanib
    D.3.2Product code [BIBF 1120]
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNINTEDANIB
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1724
    D.3 Description of the IMP
    D.3.1Product nameNintedanib
    D.3.2Product code [BIBF 1120]
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNINTEDANIB
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Systemic Sclerosis associated Interstitial Lung Disease
    pazienti con Malattia Interstiziale del Polmone associata a Sclerosi Sistemica
    E.1.1.1Medical condition in easily understood language
    scleroderma related lung fibrosis
    pazienti con Malattia Interstiziale del Polmone associata a Sclerosi Sistemica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036814
    E.1.2Term Progressive systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042954
    E.1.2Term Systemic sclerosis pulmonary
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess long term safety
    of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
    L’obiettivo principale di questo studio è valutare la sicurezza a lungo termine del trattamento con
    nintedanib in pazienti con Malattia Interstiziale del Polmone associata a Sclerosi Sistemica che abbiano completato (senza
    interrompere prematuramente il farmaco dello studio) il trial madre di fase III, SENSCIS™ (1199.214).
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who completed the SENSCISTM trial per protocol and did not
    permanently discontinue blinded treatment
    2. Signed and dated written informed consent in accordance with ICHGCP
    and local legislation prior to admission to the trial
    3. Women of childbearing potential1 must be ready and able to use
    highly effective methods of birth control per ICH M3 (R2) that result in a
    low failure rate of less than 1% per year when used consistently and
    correctly as well as one barrier method for 28 days prior to and 3 months
    after nintedanib administration. A list of contraception methods meeting
    these criteria is provided in the patient information.
    1.Pazienti che abbiano completato il trial SENSCIS™ secondo protocollo e non abbiano interrotto permanentemente il trattamento
    in doppio cieco.
    2.Consenso informato scritto in accordo alle linee guida di buona pratica clinica ICH-GCP ed alla legislazione locale, firmato e
    datato prima dell’entrata nello studio.
    3.Donne in età fertile che siano pronte e in grado di usare metodi altamente efficaci di contraccezione secondo ICH M3 (R2) che
    risultino in una bassa percentuale di insuccesso inferiore all’1% per anno, quando usati costantemente e correttamente, così come
    un metodo barriera per 28 giorni prima dell’inizio del trattamento con nintedanib, durante il trial e per 3 mesi dopo l’ultima
    assunzione di nintedanib. L’elenco dei metodi contraccettivi che soddisfano questi criteri è fornito nel foglietto informativo per il
    paziente.
    E.4Principal exclusion criteria
    1. AST, ALT > 3 x ULN
    2. Bilirubin > 2 x ULN
    3. Creatinine clearance <30 mL/min
    4. Clinically relevant anaemia at investigators discretion.
    5. Bleeding risk, any of the following
    a. Known genetic predisposition to bleeding according to the judgement
    of the
    investigator
    b. Patients who require
    i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
    antagonists, direct thrombin inhibitors, heparin, hirudin)
    ii. High dose antiplatelet therapy.
    [Note: Prophylactic low dose heparin or heparin flush as needed for
    maintenance of an indwelling intravenous device (e.g. enoxaparin 4000
    I.U. s. c. per day), as well as prophylactic use of antiplatelet therapy
    (e.g.
    acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or
    equivalent doses of other antiplatelet therapy) are not prohibited].
    c. Hemorrhagic central nervous system (CNS) event after completion of
    the
    parent trial SENSCISTM
    d. Any of the following after last treatment of SENSCISTM:
    i. Haemoptysis or haematuria
    ii. Active gastro-intestinal bleeding or GI – ulcers
    iii. Gastric antral vascular ectasia (GAVE)
    iv. Major injury or surgery (investigators judgement).
    e. Coagulation parameters: International normalised ratio (INR) >2,
    prolongation
    of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5
    x
    ULN at Visit 1.
    6. New major thrombo-embolic events developed after completion of the
    parent trial
    SENSCISTM :
    a. Stroke;
    b. Deep vein thrombosis;
    c. Pulmonary embolism;
    d. Myocardial infarction.
    7. Major surgery (major according to the investigator's assessment)
    performed within the
    next 3 months
    8. Time period > 12 weeks between last drug intake in SENSCISTM and
    Visit 2 of this trial.
    9. Usage of any investigational drug after completion of the parent trial
    SENSCISTM or
    planned usage of an investigational drug during the course of this trial.
    10. A disease or condition which in the opinion of investigator may put
    the patient at risk
    because of participation in this trial (e.g. clinically relevant intestinal
    pseudoobstruction)
    or limit the patient's ability to participate in this trial
    11. Chronic alcohol or drug abuse or any condition that, in the
    investigator's opinion, makes
    them an unreliable trial subject or unlikely to complete the trial
    12. Known hypersensitivity to the trial medication or its components (i.e.
    soya lecithin).
    13. Women who are pregnant, nursing, or who plan to become pregnant
    while in the trial
    14. Previous enrolment in this trial
    1.Aspartato aminotransferasi, alanina aminotransferasi > 3 volte il limite superiore di normalità.
    2.Bilirubina > 2 volte il limite superiore di normalità.
    3.Clearance della creatinina < 30 mL/min.
    4.Anemia clinicamente significativa a giudizio dello sperimentatore.
    5.Rischio di sanguinamento, qualsiasi delle seguenti condizioni
    a.Predisposizione genetica nota al sanguinamento, a giudizio dello sperimentatore.
    b.Pazienti che richiedano
    i.Fibrinolisi, anticoagulazione terapeutica a dose piena (ad es. antagonisti della vitamina K, inibitori diretti della trombina, eparina,
    irudina)
    ii.Terapia antiaggregante a dose piena.
    [Nota: Non è proibita la profilassi con eparina a basso dosaggio o flush di eparina al bisogno per il mantenimento di un dispositivo
    intravenoso permanente (ad es. enoxaparina 4000 I.U. s.c. al dì), così come uso profilattico di terapia antiaggregante (ad es. acido
    acetil salicilico fino a 325 mg/die, o clopidogrel a 75 mg/die, o dosi equivalenti di altre terapie antiaggreganti)].
    c.Anamnesi di eventi emorragici del sistema nervoso centrale dopo il completamento del trial madre SENSCISTM
    d.Qualsiasi delle seguenti condizioni dopo l’ultimo trattamento del SENSCISTM:
    i.Emottisi o ematuria
    ii.Sanguinamento gastro-intestinale attivo o ulcere gastro-intestinali
    iii.ectasia vascolare gastrica antrale (GAVE)
    iv.Lesione o chirurgia maggiore (a giudizio dello sperimentatore).
    e.Parametri della coagulazione: rapporto normalizzato internazionale (INR) > 2, prolungamento del tempo di protrombina (PT) e
    del tempo parziale di tromboplastina (PTT) > 1.5 volte il limite superiore di normalità alla Visita 1.
    6.Nuovi eventi trombo-embolici maggiori sviluppati dopo il completamento del trial madre SENSCISTM.
    a.ictus;
    b.trombosi venosa profonda;
    c.embolia polmonare;
    d.infarto miocardico.
    7.Procedure chirurgiche maggiori (severità a giudizio dello sperimentatore) eseguite entro i 3 mesi successivi.
    8.Intervallo di tempo > 12 settimane tra l’ultima assunzione di farmaco nello studio SENSCISTM e la Visita 2 di questo trial.
    9.Uso di qualsiasi farmaco sperimentale dopo il completamento dello studio madre SENSCISTM o uso pianificato di un farmaco
    sperimentale nel corso dello studio.
    10.Altre patologie o condizioni che a giudizio dello sperimentatore possano mettere a rischio il paziente per il fatto di partecipare a
    questo studio (ad es. pseudoostruzione intestinale clinicamente significativa) o limitare l’abilità del paziente di partecipare a
    questo studio.
    11.Abuso cronico di alcol o droghe o una qualsiasi condizione che, a giudizio dello sperimentatore, renda il paziente un soggetto
    inaffidabile o a bassa probabilità di completare lo studio.
    12.Ipersensibilità nota al farmaco dello studio o ai suoi componenti (ovvero lecitina di soia).
    13.Donne in gravidanza, in allattamento, o che pianifichino di intraprendere una gravidanza durante la partecipazione allo studio.
    14.Precedente reclutamento in questo trial.
    E.5 End points
    E.5.1Primary end point(s)
    1) The primary endpoint is the incidence of
    overall adverse events over
    1) L’endpoint primario è l’incidenza degli eventi avversi nel corso dello studio di estensione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) up to 34 months
    1) Fino a 34 mesi
    E.5.2Secondary end point(s)
    N.A.
    N.A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    N.A.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    China
    India
    Israel
    Japan
    Malaysia
    Mexico
    Thailand
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned 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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    nessuno
    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 Decision2018-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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