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    Summary
    EudraCT Number:2016-000489-50
    Sponsor's Protocol Code Number:AC-009-IT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2016-000489-50
    A.3Full title of the trial
    A Phase II, Single Arm, Open Label, Efficacy and Safety Study of NEOD001 in Subjects with Light Chain (AL) Amyloidosis with Hepatic Involvement
    Studio di fase II, open label, a singolo braccio, teso a valutare l'efficacia e la sicurezza di NEOD001 in pazienti con amiloidosi AL e coinvolgimento epatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of NEOD001 in subjects with light chain (AL) amyloidosis with hepatic involvement
    Valutazione dell'efficacia e dellala sicurezza di NEOD001 in pazienti con amiloidosi AL e coinvolgimento epatico
    A.3.2Name or abbreviated title of the trial where available
    ---
    ---
    A.4.1Sponsor's protocol code numberAC-009-IT
    A.5.4Other Identifiers
    Name:NEOD001-IST101Number:NA
    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 SponsorFONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
    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 supportProthena Therapeutics Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Policlinico San Matteo
    B.5.2Functional name of contact pointCentro per lo studio e la cura dell
    B.5.3 Address:
    B.5.3.1Street AddressP.le Golgi 19
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382502994
    B.5.5Fax number0382502990
    B.5.6E-mailsegreteria.amiloidosi@smatteo.pv.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/100
    D.3 Description of the IMP
    D.3.1Product nameNEOD001
    D.3.2Product code NEOD001
    D.3.4Pharmaceutical form Powder 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.3.9.2Current sponsor codeNEOD001
    D.3.9.3Other descriptive nameHumanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) 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.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
    AL amyloidosis with hepatic involvement
    Amiloidosi AL con coinvolgimento epatico
    E.1.1.1Medical condition in easily understood language
    Light chain (AL) amyloidosis with hepatic involvement
    Amiloidosi a catene leggere (AL) con coinvolgimento del fegato
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075251
    E.1.2Term Hepatic amyloidosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of NEOD001 in subjects with AL amyloidosis with hepatic involvement by assessing organ response.
    Valutare l'efficacia di NEOD001 in pazienti con amiloidosi AL e coinvolgimento epatico, valutando la risposta d'organo
    E.2.2Secondary objectives of the trial
    ¿ To evaluate liver stiffness using elastogram
    ¿ To evaluate safety
    ¿ To evaluate general health-related quality of life using the Short Form-36 (SF-36) Health Survey
    ¿ To evaluate additional hepatic response rates
    ¿ To evaluate cardiac response rates in a subset of patients with cardiac involvement
    ¿ To evaluate renal response rates in a subset of patients with renal involvement
    ¿ Valutare l¿elasticit¿ epatica tramite elastografia
    ¿ Valutare la sicurezza di NEOD001
    ¿ Valutare la qualit¿ di vita correlata allo stato di salute generale mediante il questionario breve SF-36 (Short Form- 36)
    ¿ Valutare il tasso di risposta epatica
    ¿ Valutare la risposta cardiaca in pazienti con coinvolgimento cardiaco
    ¿ Valutare la risposta renale in pazienti con coinvolgimento renale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age =18 years
    2. Confirmed diagnosis of systemic AL amyloidosis by the following:
    a. histochemical diagnosis of amyloidosis determined by polarizing light microscopy of green birefrigent material in Congo red-stained tissue specimens OR characteristic electron microscopy appearance AND
    b. confirmatory electron microscopy immunohistochemistry OR mass spectroscopy of AL amyloidosis
    3. Hepatic involvement and measurable liver disease as defined by hepatomegaly (total liver span of >15 cm) by CT or alkaline phosphatase >2 times the upper limit of normal [× ULN])
    4. Stable disease defined as no change in the clonal status and liver involvement during the last 6 months
    5. Seated systolic blood pressure 100-180 mmHg
    6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days prior to the first administration of study drug and agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
    7. Males must be surgically sterile or must agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
    8. Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures
    1. Età pari o superiore a 18 anni
    2. Diagnosi confermata di amiloidosi AL in base a quanto segue:
    a. Diagnosi istochimica di amiloidosi determinata mediante microscopia a luce polarizzata di materiale birifrangente verde in campioni di tessuto colorati con rosso Congo O aspetto caratteristico al microscopio elettronico
    E
    b.Immunoistochimica O spettroscopia di massa che conferma l'amiloidosi AL
    3. Coinvolgimento epatico e presenza di patologia epatica definibile in base alla presenza di epatomegalia (total liver span of >15 cm) valutata tramite TC o fosfatasi alcalina >2 volte il limite di riferimento [× url]
    4. Malattia stabile definite come assenza di cambiamento nello stato clonale e nel coinvolgimento epatico durante i sei mesi precedenti
    5. Pressione arteriosa sistolica in posizione seduta 90-180 mmHg
    6. Le pazienti in età fertile (WOCBP) devono presentare un test di gravidanza negativo nei 14 giorni prima della prima somministrazione del farmaco dello studio e devono accettare di utilizzare un metodo contraccettivo approvato dal medico a partire da 30 giorni prima della prima somministrazione fino a 90 giorni dopo l'ultima somministrazione del farmaco dello
    7. I pazienti di sesso maschile devono essere chirurgicamente sterili o devono accettare di utilizzare un metodo contraccettivo approvato dal medico a partire da 30 giorni prima della prima somministrazione fino a 90 giorni dopo l'ultima somministrazione del farmaco dello studio
    8. Capacità di comprendere e disponibilità a firmare un modulo di consenso informato prima di avviare qualsiasi procedura dello studio
    E.4Principal exclusion criteria
    1. Non-AL amyloidosis
    2. Advanced cardiac disease as defined by cardiac troponin I >0.1 ng/mL (or troponin T >0.035 ng/mL, or high-sensitivity troponin T >77 ng/L) AND NT-proBNP >8,500 ng/L
    3. Severe renal disease as defined by estimated glomerular filtration rate (eGFR) <30 mL/min
    4. End stage liver disease as defined by total bilirubin 5 × ULN
    5. Meets any of the following diagnostic criteria for symptomatic multiple myeloma:
    • lytic lesions on skeletal survey or computerized tomography (CT) scan
    • plasmacytoma
    • bone marrow plasma cells =30%
    • hypercalcemia
    • anemia without explanation
    Note: subjects who meet the International Myeloma Working Group (IMWG) definition of symptomatic multiple myeloma with symptoms attributable only to associated amyloidosis are potentially eligible
    6. Eligible for and plans to undergo ASCT or other chemotherapy
    7. Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject’s ability to safely receive treatment or complete study assessments
    8. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the Month 1 Day 1 Visit
    9. ECG evidence of acute ischemia or active conduction system abnormalities with the exception of any of the following:
    • 1st degree AV-block
    • 2nd degree AV-block Type 1 (Mobitz Type 1/ Wenckebach type)
    • Right bundle branch block
    • Atrial fibrillation with a controlled ventricular rate
    10. Received any of the following within the specified time frame prior to the first administration of study drug (ie, Month 1 Day 1 Visit):
    • Oral or intravenous antibiotics, antifungals, or antivirals within 1 week, with the exception of prophylactic oral agents (administration of doxycycline is not allowed)
    • Hematopoietic growth factors, transfusions of blood or blood products within 1 week
    • Radiotherapy within 4 weeks
    • Major surgery within 4 weeks or planned major surgery during the study
    • NEOD001 at any time
    • Another investigational agent within 30 days
    11. Active malignancy with the exception of any of the following:
    • Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
    • Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for 2 years
    • Stage I prostate cancer that does not require treatment
    • Any other cancer from which the subject has been disease-free for =2 years
    12. History of Grade =3 infusion-associated adverse events (AEs) or hypersensitivity to another monoclonal antibody
    13. Uncontrolled, active HIV, Hepatitis B, or Hepatitis C infection
    14. Women who are lactating
    15. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject’s risk by participating in the study
    1. Amiloidosi non-AL
    2. Malattia cardiaca avanzata definita da Troponona I cardiaca (cTnI) >0,1 ng/mL (o Troponina T cardiaca (cTnT) >0.035 ng/mL, o troponina T ad alta sensibilità (hs-cTnT) >77 ng/L) E NT-proBNP > 8,500 ng/L
    3. Malattia renale severa, definita come velocità di filtrazione glomerulare stimata (eGFR) <30 mL/min
    4. Malattia renale allo stadio finale, definita come valore di bilirubina totale >5× ULN
    5. I pazienti non devono soddisfare nessuno dei seguenti criteri diagnostici per il mieloma multiplo sintomatico:
    • lesioni ossee litiche valutate tramite radiografia dello scheletro o TAC
    • Plasmacitoma
    • Infiltrato plasmacellulare nel midollo osseo =30%
    • Ipercalcemia
    • Anemia in assenza di altra spiegazione
    *Si noti che i pazienti che rispondono alla definizione dell’International Myeloma Working Group (IMWG) di mieloma multiplo sintomatico con segni e/o sintomi attribuibili solo ad amiloidosi associata sono potenzialmente elegibili.
    6. Paziente idoneo e che preveda di sottoporsi a ASCT o altra chemioterapia
    7. Ipotensione ortostatica sintomatica che secondo il giudizio medico dello sperimentatore potrebbe interferire con la capacità del paziente di sottoporsi in modo sicuro al trattamento o completare gli esami dello studio
    8. Infarto miocardico, angina non controllata, gravi aritmie ventricolari non controllate o evidenza elettrocardiografica di ischemia acuta nei 6 mesi precedenti la visita del giorno 1 del mese 1
    9. Evidenza elettrocardiografica di ischemia acuta o anomalie attive del sistema di conduzione, ad eccezione di una qualsiasi delle seguenti condizioni:
    • Blocco AV di primo grado
    • Blocco AV di secondo grado Tipo 1 (Mobitz Tipo 1 / Tipo Wenckebach)
    • Blocco di branca destra
    • Fibrillazione atriale con frequenza ventricolare controllata
    10. Utilizzo dei seguenti
    • Utilizzo di antibiotici, antifungini o antivirali per via orale o EV entro 1 settimana dal giorno 1 del mese 1, ad eccezione degli agenti profilattici orali (la somministrazione di doxiciclina non è permessa)
    • Precedente trattamento con fattori della crescita emopoietici, trasfusioni di sangue o emoderivati entro 1 settimana dal giorno 1 del mese 1
    • Precedente radioterapia o chemioterapia entro 4 settimane dal giorno 1 del mese 1
    • Intervento chirurgico maggiore entro 4 settimane dal giorno 1 del mese 1 o programmato nel corso dello studio
    • NEOD001 in nessun momento
    • Trattamento con un altro agente sperimentale entro 30 giorni
    11. Neoplasia attiva ad eccezione di una qualsiasi delle seguenti condizioni:
    • Carcinoma basocellulare, carcinoma squamocellulare o cancro cervicale in situ adeguatamente trattato
    • Cancro allo stadio I adeguatamente trattato da cui il paziente è attualmente in fase di remissione e lo è da 2 anni
    • Cancro alla prostata allo stadio I che non richiede trattamento
    • Qualsiasi altro cancro da cui il paziente è libero da = 2 anni
    12. Anamnesi di eventi indesiderati (AE) associati all'infusione di grado = 3 o ipersensibilità a un altro anticorpo monoclonale
    13. Infezione attiva da HIV, epatite B o epatite C non controllata
    14. Pazienti in gravidanza o che allattano al seno
    15. Qualsiasi condizione in grado di interferire con la conduzione dello studio, o con il trattamento per il quale lo studio viene condotto, o che, a giudizio dello sperimentatore, potrebbe comportare un aumento inaccettabile del rischio per il paziente qualora partecipasse allo studio
    E.5 End points
    E.5.1Primary end point(s)
    Hepatic best response from Screening/Baseline to Month 6 defined as reduction in alkaline phosphatase of at least 50% or decrease in liver major diameter of at least 30% (by CT scan)
    Migliore risposta epatica dal basale/screening al mese 6, definita come riduzione della fosfatasi alcalina almeno del 50%, o diminuzione del maggiore diametro epatico di almeno il 30% (determinazione tramite TC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 6
    mese 6
    E.5.2Secondary end point(s)
    Liver elasticity as measured by elastogram at Months 6 and 12; Safety as assessed by vital signs, duration of therapy, 12 lead ECGs, routine laboratory assessments, and frequency and severity of AEs; Change from Screening/Baseline to Months 6, 9, and 12 in the SF-36 ; Hepatic best response from Screening/Baseline to Months 3, 9, and 12; For cardiac evaluable subjects: NT-proBNP best response from Baseline to Month 12 ; For renal evaluable subjects: proteinuria best response from Baseline to Month 12
    Elasticit¿ epatica misurata tramite elastografia al mese 6 e al mese 12; Profilo di sicurezza come stabilito dai segni vitali, durata complessiva della terapia, 12 lead ECGs, esami di laboratorio, frequenza e grado di severit¿ degli eventi avversi; Variazione dal basale/screening ai mesi 6, 9 e 12 nell'SF-36 ; Migliore risposta epatica dal basale/screening al mese 3, 9 e 12; Per soggetti con interessamento cardiaco: migliore risposta cardiaca valutata tramite la riduzione dell¿NT-proBNP dal basale/screening al mese 12 ; Per soggetti con interessamento renale: migliore risposta renale valutata come riduzione della proteinuria dal basale al mese 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    months 6 and 12; At end of study; months 6, 9, and 12; months 3, 9, and 12; month 12; month 12
    mesi 6 e 12; A fine studio; mesi 6, 9 e 12 ; mesi 3, 9 e 12; mese 12; mese 12
    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 Yes
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    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 months24
    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 months24
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    Survey for relapse, according to clinical practice
    Sorveglianza per possibile recidive, secondo pratica clinica
    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 Decision2017-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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