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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2014-001032-11
    Sponsor's Protocol Code Number:OMS721-TMA-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-07
    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 number2014-001032-11
    A.3Full title of the trial
    A Phase 2, uncontrolled, two-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics,
    immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies.
    Studio di coorte di fase II, non controllato, a tre stadi e a dosi crescenti volto a valutare la sicurezza, la farmacocinetica, la farmacodinamica, l¿immunogenicit¿ e l¿attivit¿ clinica di OMS721 in soggetti adulti affetti da microangiopatie trombotiche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with
    thrombotic microangiopathies.
    Studio per investigare la sicurezza, la farmacocinetica, farmacodinamica, immunogenicit¿, e l'attivit¿ clinica di OMS721 in adulti affetti da microangiopatie trombotiche
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberOMS721-TMA-001
    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 SponsorOMEROS CORPORATION
    B.1.3.4CountryRwanda
    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 supportOmeros Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI CRO AG
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressBaarestrasse 113a
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0048222100200
    B.5.5Fax number0048222100220
    B.5.6E-mailmalgorzata.kozak-regwelska@psi-cro.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.3.2Product code OMS721
    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.3.9.2Current sponsor codeOMS721
    D.3.9.3Other descriptive nameOMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    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
    Three forms of thrombotic microangiopathies (TMA):
    - atypical hemolytic uremic syndrome (aHUS).
    - hematopoietic stem cell transplant (HSCT)-associated TMA.
    - thrombotic thrombocytopenic purpura (TTP).
    Sindrome emolitico-uremica atipica (atypical hemolytic uremic syndrome, aHUS), TMA associata a trapianto di cellule staminali ematopoietiche (hematopoietic stem cell transplant, HSCT) e porpora trombotica trombocitopenica (PTT).
    E.1.1.1Medical condition in easily understood language
    Thrombosis in capillaries and arterioles.
    Trombosi in capillari e arteriole.
    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 10043645
    E.1.2Term Thrombotic microangiopathy
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the safety and tolerability of multiple-dose administration of OMS721 in subjects with TMA.
    Evaluate the clinical activity of multiple-dose administration of OMS721 in subjects with TMA.
    Valutare la sicurezza e la tollerabilit¿ della somministrazione di dosi multiple di OMS721 in soggetti affetti da microangiopatie trombotiche (thrombotic microangiopathy, TMA).
    Valutare l¿attivit¿ clinica della somministrazione di dosi multiple di OMS721 in soggetti affetti da TMA
    E.2.2Secondary objectives of the trial
    Determine the pharmacokinetics (PK) of multiple-dose administration of OMS721 in subjects with TMA.
    Determine the pharmacodynamics (PD) of multiple-dose administration of OMS721 in subjects with TMA.
    Determine the immunogenicity of multiple-dose administration of OMS721 in subjects with TMA.
    Determinare la farmacocinetica della somministrazione di dosi multiple di OMS721 in soggetti affetti da TMA.
    Determinare la farmacodinamica della somministrazione di dosi multiple di OMS721 in soggetti affetti da TMA.
    Determinare la risposta degli anticorpi anti-farmaco alla somministrazione di dosi multiple di OMS721 in soggetti affetti da TMA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Competent to provide informed consent.
    2. Voluntarily provide informed consent in accordance with local regulations and governing
    ethics committee requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
    3. Are age =18 at screening (Visit 1).
    4. Have a diagnosis of one of the following TMAs:
    • Primary aHUS, diagnosed clinically and having ADAMTS13 activity > 10% in plasma. Patients are eligible with or without a documented
    complement mutation or anti-CFH antibody. Patients are categorized according to their response to plasma therapy (plasma exchange or plasma infusion):
    o Plasma therapy-resistant aHUS patients must have all of the following:
    1) screening platelet count < 150,000/µL despite at least four plasma therapy treatments prior to screening; 2) evidence of microangiopathic hemolysis (presence of schistocytes, serum lactate dehydrogenase (LDH) > upper limit of normal (ULN), haptoglobin < LLN); and 3) serum creatinine > ULN.
    o Chronic plasma therapy-responsive aHUS patients (plasma therapysensitive) must require at least once-per-week plasma therapy for four weeks before first dose of OMS721 with serum creatinine > ULN.
    • TTP defined as having all of the following:
    o Platelet count < 150,000/µL
    o Evidence of microangiopathic hemolysis (presence of schistocytes, serum LDH > ULN, or haptoglobin < LLN)
    o ADAMTS13 activity = 10% during the current episode of TTP or historically.
    • Persistent HSCT-associated TMA defined as having all of the following at least two weeks following modification or discontinuation of
    calcineurin inhibitor treatment or at least 30 days after the transplant:
    o Platelet count < 150,000/µL
    o Evidence of microangiopathic hemolysis (presence of schistocytes, serum LDH > ULN, or haptoglobin < LLN)
    o Renal dysfunction (doubling of serum creatinine from pre-transplant).
    5. No clinically apparent alternative explanation for thrombocytopenia and anemia.
    6. If sexually active and of childbearing potential, must agree to practice a highly effective method of birth control until the end of the study, defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices,
    sexual abstinence or vasectomized partner.
    1. Capacità di fornire il consenso informato.
    2. Consenso informato fornito volontariamente ai sensi delle normative locali e dei requisiti previsti dal comitato etico competente prima di qualsiasi procedura o valutazione condotta specificatamente per le sole finalità dello studio.
    3. Età = 18 anni allo screening (Visita 1).
    4. Diagnosi di una delle seguenti forme di TMA:
    * aHUS primaria clinicamente diagnosticata e caratterizzata da attività di ADAMTS13 > 10% nel plasma. I pazienti sono ritenuti idonei alla partecipazione a prescindere dalla presenza documentata o meno di una mutazione del complemento o di anticorpi contro il fattore H del complemento (complement factor H, CFH). I pazienti sono classificati in funzione della risposta alla terapia plasmatica (plasmaferesi o infusione di plasma).
    - I pazienti affetti da aHUS resistenti alla terapia plasmatica devono soddisfare tutti i seguenti criteri: 1) conta piastrinica allo screening < 150.000/µl nonostante almeno quattro trattamenti a base di terapia plasmatica precedente allo screening; 2) evidenza di emolisi microangiopatica (presenza di schizociti, lattato deidrogenasi (lactate dehydrogenase, LDH) sierica > limite superiore della norma (upper limit of normal, ULN), aptoglobina < limite inferiore della norma (lower limit of normal, LLN) e 3) creatinina sierica > ULN.
    - Pazienti affetti da aHUS cronica responsivi alla terapia plasmatica (sensibili alla terapia plasmatica) devono essere sottoposti a terapia plasmatica almeno una volta a settimana per quattro settimane prima della prima dose di OMS721, con creatinina sierica > ULN.
    PTT intesa come il soddisfacimento di tutti i seguenti criteri:
    o Conta piastrinica < 150.000/µl;
    o Evidenza di emolisi microangiopatica (presenza di schistociti, LDH sierica > ULN o aptoglobina < LLN);
    o Attività di ADAMTS-13 = 10% durante l’attuale episodio di PTT o nell’anamnesi.
    * TMA associata a HSCT persistente intesa come il soddisfacimento di tutti i seguenti criteri almeno due settimane dopo la modifica o l’interruzione del trattamento con inibitori della calcineurina o almeno 30 giorni dopo il trapianto:
    o Conta piastrinica < 150.000/µl;
    o Evidenza di emolisi microangiopatica (presenza di schizociti, LDH sierica > ULN o aptoglobina < LLN);
    o Disfunzione renale (raddoppiamento dei valori della creatinina sierica rispetto a prima del trapianto).
    5. Assenza di qualsivoglia spiegazione alternativa clinicamente evidente per trombocitopenia e anemia.
    6. Per i soggetti sessualmente attivi e in età fertile, consenso all’utilizzo di un metodo anticoncezionale altamente efficace fino alla fine dello studio. Con metodo anticoncezionale altamente efficace si intende un metodo che presenta un basso tasso di fallimento (inferiore all’1% all’anno) se usato in modo costante e corretto, quali impianti, contraccettivi iniettabili o orali combinati, alcuni dispositivi intrauterini, astinenza da rapporti sessuali o partner sottoposto a vasectomia.
    E.4Principal exclusion criteria
    1. Had eculizumab therapy within three months prior to screening.
    2. Have STEC-HUS.
    3. Have a positive direct Coombs test.
    4. Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered
    as standard of care is allowed).
    5. Baseline resting heart rate < 45 beats per minute or > 115 beats per minute.
    6. Baseline QTcF > 470 milliseconds.
    7. Have malignant hypertension (diastolic blood pressure > 120 mm Hg with bilateral hemorrhages or "cotton-wool" exudates on funduscopic
    examination).
    8. Have a poor prognosis with a life expectancy of less than three months in the opinion of the
    investigator.
    9. Are pregnant or lactating.
    10. Have received treatment with an investigational drug or device within four weeks prior to screening.
    11. Have abnormal liver function tests defined as ALT or AST > five times ULN.
    12. Have a positive test for human immunodeficiency virus (HIV) antibodies.
    13. Are an employee of Omeros, an investigator, a study staff member, or their immediate family
    member.
    14. Have a known hypersensitivity to any constituent of the product.
    15. Presence of any condition that the Investigator believes would put the subject at risk.
    16. Have access to eculizumab therapy.
    1. Terapia con eculizumab nei tre mesi precedenti allo screening.
    2. Sindrome emolitico-uremica da Escherichia coli produttore della tossina Shiga (Shiga toxin-producing Escherichia coli, STEC).
    3. Risultato positivo al test di Coombs diretto.
    4. Infezione fungina o batterica sistemica attiva che necessita di terapia antimicrobica (è consentita la terapia antimicrobica profilattica somministrata come trattamento standard).
    5. Frequenza cardiaca a riposo al basale < 45 battiti al minuto o > 115 battiti al minuto.
    6. Intervallo QT corretto secondo la formula di Fredericia (QTcF) > 470 millisecondi.
    7. Ipertensione maligna (pressione diastolica > 120 mm Hg con emorragie bilaterali o essudati cotonosi all’esame del fondo oculare).
    8. Prognosi infausta con aspettativa di vita inferiore a tre mesi secondo il giudizio dello sperimentatore.
    9. Gravidanza o allattamento in corso.
    10. Trattamento con farmaco o dispositivo sperimentale nelle quattro settimane precedenti allo screening.
    11. Valori anomali degli esami di funzionalità epatica, intesi come ALT o AST > cinque volte l’ULN.
    12. Risultato positivo al test per gli anticorpi contro il virus dell’immunodeficienza umana (human immunodeficiency virus, HIV).
    13. Il soggetto è un dipendente di Omeros, uno sperimentatore, un membro del personale dello studio o è legato a questi ultimi da stretti vincoli di parentela.
    14. Ipersensibilità nota a uno qualsiasi dei componenti del prodotto.
    15. Presenza di qualsiasi condizione che lo sperimentatore ritenga possa comportare un rischio per il soggetto.
    16. Accesso alla terapia con eculizumab.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety as assessed by AEs, vital signs, and clinical laboratory tests.
    • Clinical activity as assessed by platelet count.
    • Sicurezza valutata in termini di incidenza di eventi avversi (EA), segni vitali, e analisi cliniche di laboratorio.
    • Attivita clinca evaluata secondo la conta piastrinica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 hours - 1 week
    0 ore - 1 settimana
    E.5.2Secondary end point(s)
    TMA clinical activity
    o Serum LDH
    o Serum haptoglobin
    o Hemoglobin
    o Serum creatinine
    o TMA-related symptoms
    o Need for plasma therapy (plasma exchange or plasma infusion)
    o Need for dialysis; PK parameters including maximum concentration (Cmax), time to maximum concentration (Tmax), elimination half-life (t¿), area under time-concentration curve (AUC), clearance (CL), and volume of distribution (Vz); PD measure of inhibition of ex vivo lectin pathway activation.; Presence of ADA response.
    Attivita clinica di TMA
    o LDH sierica
    o Aptoglobina sierica
    o Emoglobina
    o Creatinina sierica
    o Sintomi correlati a TMA
    o Necessit¿ di terapia plasmatica (plasmaferesi o infusione di plasma)
    o Necessit¿ di dialisi; Parametri farmacocinetici tra cui la concentrazione massima (Cmax), il tempo fino alla concentrazione massima (Tmax), emivita di eliminazione (t¿), area sotto la curva tempo-concentrazione (AUC), la clearance (CL), e il volume di distribuzione (Vz); Parametro farmacodinamico (inibizione dell¿attivazione della via della lectina ex vivo).; Presenza di risposta degli anticorpi anti-farmaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    pre-dose, 5 min, 2 hour; pre-dose, 5 min, 2 hour; pre-dose, 5 min, 2 hour; pre-dose, 5 min, 2 ore
    pre-dosaggio, 5 minuti, 2 ore; pre-dosaggio, 5 minuti, 2 ore; pre-dosaggio, 5 minuti, 2 ore; pre-dosaggio, 5 minuti, 2 ore
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicit¿
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    studio a dosi crescenti
    ascending-dose-escalation study
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Belarus
    Hong Kong
    Malaysia
    New Zealand
    Taiwan
    Thailand
    Turkey
    United States
    Belgium
    Bulgaria
    Czechia
    Germany
    Italy
    Lithuania
    Poland
    Sweden
    Switzerland
    United Kingdom
    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
    LPLV
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 89
    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)
    Standard of Care.
    Standard terapeutico.
    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 Decision2015-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-25
    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-Fri May 03 16:36:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA