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    Summary
    EudraCT Number:2017-002697-39
    Sponsor's Protocol Code Number:MPOH03
    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:2020-11-10
    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 number2017-002697-39
    A.3Full title of the trial
    Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disease after Allogeneic hematopoietic stem cell transplantation with fecal microbiota transfer (HERACLES)
    Trattamento, mediante perfusione del microbiota fecale, della malattia del trapianto contro l'ospite gastrointestinale acuta refrattaria agli steroidi insorta successivamente al trapianto allogenico con cellule staminali emopoietiche (graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with fEcal microbiota tranSfer, HERACLES)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids
    Trattamento, mediante perfusione del microbiota fecale, della malattia del trapianto contro l'ospite gastrointestinale acuta refrattaria agli steroidi insorta successivamente al trapianto allogenico con cellule staminali emopoietiche
    A.3.2Name or abbreviated title of the trial where available
    HERACLES
    HERACLES
    A.4.1Sponsor's protocol code numberMPOH03
    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 SponsorMAAT PHARMA
    B.1.3.4CountryFrance
    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 supportMAAT PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaaT Pharma
    B.5.2Functional name of contact pointDavid Salako, Project Director
    B.5.3 Address:
    B.5.3.1Street Address317 avenue Jean Jaurès
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69007
    B.5.3.4CountryFrance
    B.5.4Telephone number+33663590186
    B.5.5Fax number+33428291405
    B.5.6E-maildsalako@maat-pharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMaaT013
    D.3.2Product code [7P010]
    D.3.4Pharmaceutical form Rectal suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMaaT013
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 90
    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 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
    Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
    Malattia del trapianto verso l'ospite a carico del tratto gastrointestinale dopo trapianto allogenico di cellule staminali refrattaria agli steroidi
    E.1.1.1Medical condition in easily understood language
    Medical complication not treatable with steroids following the receipt of transplanted tissue from a genetically different person
    Complicazioni mediche non trattabili con steroidi in seguito al ricevimento di tessuto trapiantato da persona geneticamente diversa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066264
    E.1.2Term Acute graft versus host disease in intestine
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the gastrointestinal response (Complete Response (CR) and Very Good Partial Response (VGPR)) at D28 of steroid refractory (SR) gastro-intestinal (GI) acute graft-versus-host disease (aGVHD) patients treated with allogeneic Fecal Microbiota Transfer (FMT).
    Valutazione della risposta gastrointestinale (risposta completa [Complete Response, CR] e risposta parziale molto buona [Very Good Partial Response, VGPR]) al G28 dei pazienti con malattia del trapianto contro l'ospite acuta (aGVHD) a carico del tratto gastrointestinale (GI) refrattaria agli steroidi (SR) trattata con trapianto allogenico di microbiota fecale (FMT).
    E.2.2Secondary objectives of the trial
    • Evaluation of overall aGVHD response (CR e VGPR)
    • Evaluation of overall and best response rates (CR, VGPR e risp parziale [PR]) for GI and overall aGVHD
    • Evaluation of the durable overall response rate
    • Evaluation of the duration of response
    • Evaluation of safety within 24 hours after FMT as well as overall safety.
    • Evaluation of feasibility of allogeneic FMT procedure and acceptance by the patient
    • Evaluation of clinical safety and performance of MaaT's medical device
    • Evaluation of the number of patients receiving the full treatment sequence (3 FMTs)
    • Evaluation of FMT activity and/or impact on:
    - Steroid-free, progression-free survival, relapse of the initial disease, GVHD-free survival, GVHD and relapse-free survival, overall survival.
    - Infectious disorders, Multi-Drug Resistant Bacteria (MDRB) carriage, Clinical symptoms of skin/liver aGVHD associated with SR-GI-aGVHD, Stool evaluation, Quality of Life (QoL)
    Valutaz della risp complessiva della aGVHD (CR e VGPR)
    •Valutazione dei tassi di risp complessiva e migliore (CR, VGPR e risp parziale [PR]) per la aGVHD complessiva e afferente al tratto GI
    •Valutaz del tasso di risp complessiva durevole
    •Valutaz durata risp
    •Valutaz sicurezza nelle 24 ore successive all'FMT nonché della sicurezza complessiva
    •Valutaz fattibilità della procedura di FMT allogenico e accettazione da parte del pz
    •Valutaz sicurezza clinica e prestazioni dispositivo medico di Maat
    •Valutaz nr pazienti riceventi la sequenza completa (3 FMT)
    •Valutaz attività e/o dell'impatto FMT su:
    -Assenza di terapia steroidea, sopravv libera da progressione, recidiva malattia iniziale, sopravv libera da GVHD, sopravv libera da recidiva e GVHD, e sopravv complessiva
    -Patologie infettive
    -Trasporto di batteri resistenti a molteplici farmaci
    -Sintomi clinici di aGVHD a carico di cute/fegato in associazione a GI-aGVHD refrattaria agli steroidi
    -Valutaz feci
    -Qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients who develop a first episode of Stage 3 or 4 GI-aGVHD with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with
    steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone
    equivalent dose) (SR GI-aGVHD)
    -Age = 18 years old
    -Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
    -Patients able to have a minimum of 12 hours discontinuation of
    systemic antibiotics in order to perform the allogeneic FMT (for patient who received antibiotics MaaT Pharma advises against the use of antibiotics (commonly used) with significant digestive excretion (for example but not limited to: metronidazol, ceftriaxone, levofloxacin))
    -Signature of informed and written consent by the subject or by the subject's legally acceptable representative
    -Pazienti che sviluppano un primo episodio di GI-aGVHD di stadio III o IV con predominanza intestinale (Przepiorka D, 1995), resistente a una
    terapia steroidea di prima linea (assenza di miglioramento dopo 5 giorni o progressione dopo 3 giorni di trattamento con corticosteroidi a dosi equivalenti a 2 mg/kg di metilprednisolone) (GI-aGVHD refrattaria agli steroidi)
    -Età =18 anni
    -Trapianto allogenico di cellule staminali mopoietiche (Hematopoietic Stem Cell Transplantation, HSCT) con qualsiasi tipo di donatore, fonte di cellule staminali, profilassi per la GVHD o regime di condizionamento
    -Pazienti in grado di interrompere per almeno 12 ore la terapia antibiotica sistemica per eseguire l'FMT allogenico (per i pazienti che hanno ricevuto le raccomandazioni da parte di MaaT Pharma contro l'uso degli antibiotici di uso comune associati ad escrezioni significative nell'apparato digerente, tra cui, a titolo meramente esemplificativo, metronidazolo, ceftriaxone, levofloxacina)
    -Sottoscrizione del consenso informato scritto da parte del soggetto o del suo rappresentante legalmente accettabile
    E.4Principal exclusion criteria
    Grade IV hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba RM, 2007)
    • Late-onset aGVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
    • Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
    • Acute GVHD after donor lymphocytes infusion (DLI)
    • Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
    • Active uncontrolled infection according to the attending physician
    • Current or past veno-occlusive disease or other uncontrolled complication unlesso therwise agreed in writing by the Sponsor.
    • Systemic drugs other than corticosteroids for GvHD treatment, including extra-corporeal photopheresis (ECP), unless treatments began before or concomitantly with corticosteroid treatment. New therapies after corticosteroids are a definitive non-inclusion criterium.
    • Drugs for GvHD prevention (e.g., calcineurin inhibitors, Mycophenolate mofetil (MMF), ECP…), are allowed as long as treatment began before or
    concomitantly with the corticosteroid treatment.
    • Absolute neutrophil count < 0.5 x 109 /L
    • Absolute platelet count < 10 000
    • Patient with negative IgG EBV serology
    • Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation on abdominal X-ray
    • Known allergy or intolerance to trehalose or maltodextrin
    • Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention
    • Pregnancy: positive urinary or blood test in females of childbearing potential; lactation; absence of effective contraceptive method for
    females of childbearing potential throughout the entire duration of the study
    • Other ongoing interventional protocol that might interfere with the current study's primary endpoint.
    GVHD iperacuta di grado IV come definita dai criteri dell'MD Anderson (Saliba RM, 2007)
    • aGVHD ad insorgenza tardiva come definita dai criteri del NIH Consensus (Jagasia MH, 2015)
    • GVHD cronica sovrapponentesi come definita dai criteri del NIH Consensus (Jagasia MH, 2015)
    • GVHD acuta dopo infusione di linfociti da donatore (Donor Lymphocytes Infusion, DLI)
    • Neoplasia maligna recidiva/persistente che rende necessaria la rapida interruzione dell'immunosoppressione
    • Infezione attiva non controllata secondo il medico curante
    • Malattia veno-occlusiva attuale o pregressa o altra complicanza incontrollata, se non diversamente concordato per iscritto dallo Sponsor.
    • Uso di farmaci sistemici diversi dai corticosteroidi per il trattamento della GVHD, ivi inclusa la fotoferesi extracorporea (Extra-Corporeal Photopheresis, ECP), a meno che il trattamento non sia stato avviato prima della terapia a base di corticosteroidi o in concomitanza con la stessa. Eventuali nuove terapie avviate dopo quella con i corticosteroidi rappresentano un criterio di esclusione definitivo
    • Sono ammessi i farmaci per la prevenzione della GVHD (ad es. inibitori della calcineurina, micofenolato mofetile [MMF], ECP), purché il trattamento sia stato avviato prima della terapia a base di corticosteroidi o in concomitanza con la stessa
    • Conta assoluta dei neutrofili <0,5 x 109/l
    • Conta assoluta delle piastrine <10.000
    • Pazienti con sierologia IgG negativa all'EBV
    • Evidenza attuale o pregressa di megacolon tossico, occlusione intestinale o perforazione gastrointestinale rilevati mediante radiografia addominale
    • Allergia o intolleranza nota al trealosio o alla maltodestrina
    • Pazienti vulnerabili quali: minori di età, persone private della libertà, persone in terapia intensiva incapaci di fornire e sottoscrivere il consenso informato precedentemente al trattamento
    • Gravidanza: test sul sangue o sulle urine positivo in donne fertili; allattamento; mancato utilizzo di metodi anticoncezionali efficaci per le donne fertili per tutta la durata dello studio
    • Partecipazione ad un altro protocollo interventistico in corso che potrebbe interferire con l'endpoint primario dello studio ivi descritto
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of FMT in the treatment of SR-GI-aGVHD at D28 post inclusion (V4):
    Number and proportion of patients achieving GI aGVHD response by D28, defined as Complete response or Very Good Partial Response
    Efficacia dell'FMT nel trattamento della GI-aGVHD refrattaria agli steroidi al G28 dopo l'inclusione (V4):
    Numero e percentuale di pazienti che ottengono una risposta della aGVHD complessiva e afferente al tratto GI entro il G28, definita come risposta completa o risposta parziale molto buona
    E.5.1.1Timepoint(s) of evaluation of this end point
    D28 post inclusion (V4)
    Giorno 28 dopo inclusione nello studio (V4)
    E.5.2Secondary end point(s)
    1) Efficacy of FMT in the treatment of overall aGVHD at D28 post inclusion (V4):
    2)Evaluation of overall and best response rates (CR, VGPR and Partial Response (PR)) for both GI and overall aGVHD
    3)Evaluation of the durable overall response rate
    4)Evaluation of the duration of response
    5)Safety of FMT in patients with SR-GI-aGVHD
    6) Feasibility of allogeneic FMT procedure and acceptability by the patient
    7) Number of patients receiving 3 FMTs
    8) Clinical safety and performance of MaaT Pharma's medical device (Directive 9342 CE, med dev 2.7.1)
    9) Evaluation of FMT activity and/or impact on steroid-free, progression-free survival, relapse of the initial disease, GVHD-free survival, GVHD
    and relapse-free survival and overall survival
    10) Evaluation of FMT activity and/or impact on infectious disorders
    11) Evaluation of FMT activity and/or impact on MDRB carriage
    12) Evaluation of FMT activity and/or impact on clinical symptoms of skin/liver aGVHD associated with SR-GI-aGVHD
    13) Stool evaluation (volume of diarrhea, Bristol stool chart)
    14) Evaluation of microbiota reconstitution
    15) Chronic GVHD incidence and severity
    16) Assessment of a microbiota signature (Exploratory)
    17) Impact of FMT on the immune system (Exploratory)
    1) Efficacia dell’FMT nel trattamento dell’aGVHD complessiva al G28 dopo l’inclusione (V4)
    2) Valutazione dei tassi di risposta complessiva e migliore (CR, VGPR e risposta parziale [PR]) per la aGVHD sia complessiva sia afferente al tratto GI
    3) Valutazione del tasso di risposta complessiva durevole
    4. Valutazione della durata della risposta
    5)Sicurezza dell'FMT nei pazienti con GI-aGVHD refrattaria agli steroidi.
    6) Fattibilità della procedura di FMT allogenico e accettabilità da parte del paziente
    7) Numero di pazienti che ricevono 3 FMT
    8) Sicurezza clinica e prestazioni del dispositivo medico di Maat Pharma (Direttiva 9342 CE, dispositivi medici 2.7.1)
    9) Valutazione dell'attività e/o dell'impatto dell'FMT su: assenza di terapia steroidea, sopravvivenza libera da progressione, recidiva della malattia iniziale, sopravvivenza libera da GVHD, sopravvivenza libera da recidiva e da GVHD e sopravvivenza complessiva
    10) Valutazione dell'attività e/o dell'impatto dell'FMT sulle patologie infettive
    11) Valutazione dell'attività e/o dell'impatto dell'FMT sul trasporto di MDRB
    12) Valutazione dell'attività e/o dell'impatto dell'FMT sui sintomi clinici della aGVHD a carico di cute/fegato in associazione a GI-aGVHD refrattaria agli steroidi
    13) Valutazione delle feci (volume della diarrea, scala delle feci di Bristol)
    14) Valutazione della ricostituzione del microbiota
    15) Incidenza e gravità della GVHD cronica
    16) Valutazione di una firma del microbiota (esplorativa)
    17) Impatto dell’FMT sul sistema immunitario (esplorativo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    D28 post inclusion (V4), M3 (V5), M6 (V6) and M12 (V12)
    Giorno 28 dopo inclusione nello studio (V4), M3 (V5), M6 (V6) e M12 (V12)
    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 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 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
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject´s legal representative may sign informed consent form.
    Vulnerable patients (Minor, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention) will not be included in the trial.
    Il tutore legale del soggetto può firmare il modulo di consenso. Pazienti vulnerabili (minori, persone senza libertà, persone in terapia intensiva non in grado di fornire il consenso informato prima dell'intervento) non saranno inclusi nello studio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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 Decision2018-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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