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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2016-004339-19
    Sponsor's Protocol Code Number:UTX-TGR-204
    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:2020-10-06
    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 number2016-004339-19
    A.3Full title of the trial
    A Multi-Center, Open-Label, Extension Study of Ublituximab (TG-1101) in Combination with TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
    Studio di estensione multicentrico, in aperto di ublituximab (TG-1101) in combinazione con TGR-1202 per pazienti gi¿ arruolati nel protocollo UTX-TGR-304
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension Study for Patients Previously Enrolled in Protocol UTX-TGR-304
    Studio di estensione per pazienti precedentemente arruolati nel protocollo UTX-TGR-304
    A.3.2Name or abbreviated title of the trial where available
    Extension Study for Patients Previously Enrolled in Protocol UTX-TGR-304
    Studio di Estensione per pazienti precedentemente arruolati nel protocollo UTX-TGR-304
    A.4.1Sponsor's protocol code numberUTX-TGR-204
    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 SponsorTG THERAPEUTICS, INC.
    B.1.3.4CountryUnited States
    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 supportTG therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge Regulatory Services Ltd
    B.5.2Functional name of contact pointRegulatory Services
    B.5.3 Address:
    B.5.3.1Street Address2 Cabot House, Compass Point Business Park Stocks Bridge Way
    B.5.3.2Town/ citySt Ives, Cambridgeshire
    B.5.3.3Post codePE27 5JL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441480465755
    B.5.5Fax number00441480463984
    B.5.6E-mailpallavshah@cambreg.co.uk
    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 nameUblituximab
    D.3.2Product code TG-1101
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.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 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 nameTGR-1202
    D.3.2Product code TGR-1202
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTGR-1202
    D.3.9.2Current sponsor codeTGR-1202
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Chronic Lymphocytic Leukemia
    Leucemia linfocitica cronica
    E.1.1.1Medical condition in easily understood language
    Leukemia
    Leucemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For patients previously on Arms B, C, & D of Study UTX-TGR-304:
    Primary Objective
    ¿ To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR)

    For patients previously on Arm A of Study UTX-TGR-304:
    Primary Objective
    ¿ To evaluate the progression-free survival (PFS) and duration of response (DOR)
    Per i pazienti dei bracci B, C e D dello studio UTX-TGR-304, l'obbiettivo primario ¿ determinare il tasso di risposta globale (ORR) definito come la somma delle risposte complete e le riposte parziali.
    Per i pazienti del braccio A dello studio UTX-TGR-304, l'obbiettivo primario ¿ valutare il periodo di sopravvivenza privo di progressione (PFS) e la durata della risposta (DOR).
    E.2.2Secondary objectives of the trial
    For patients previously on Arms B, C, & D of Study UTX-TGR-304:
    Secondary Objective
    ¿ To evaluate the progression-free survival (PFS) and duration of response (DOR)
    ¿ To evaluate the % of patients that achieve MRD negativity
    ¿ To evaluate the safety of ublituximab in combination with TGR-1202

    For patients previously on Arm A of Study UTX-TGR-304:
    Secondary Objective
    ¿ To evaluate the safety of ublituximab in combination with TGR-1202
    Per i pazienti in precedenza in bracci B, C, & D di studio UTX-TGR-304 l'obbiettivo secondario ¿
    -valutare la sopravvivenza libera da progressione (PFS) e la durata della risposta (DOR)
    -valutare la percentuale di pazienti che raggiungono la negativit¿ MRD
    - valutare la sicurezza di ublituximab in combinazione con TGR-1202
    Per i pazienti in precedenza sul braccio A di studio UTX-TGR-304 l'obiettivo secondario ¿ valutare la sicurezza di ublituximab in combinazione con TGR-1202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior treatment in clinical trial UTX-TGR-304: a. Confirmed progression by IRC from either Arms B, C, or D. and b. Non-progressing patients from Arm A may be eligible for enrollment when protocol UTX-TGR-304 is completed.
    2. Adequate organ system function, defined as follows: a. absolute neutrophil count (ANC) > 750 / platelet count > 40,000; b. Total bilirubin =1.5 times the upper limit of normal (ULN); c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN if no liver involvement or =5 x the ULN if known liver involvement; d. Calculated creatinine clearance >30 mL/min (as calculated by the Cockcroft-Gault formula)
    3. ECOG performance status = 2
    4. Ability to swallow and retain oral medication
    5. Willingness and ability to comply with trial and follow-up procedures, give written informed consent
    1. Precedente trattamento nella sperimentazione clinica UTX-TGR-304
    a. Progressione confermata dall'IRC nei bracci B, C o D
    b. I pazienti non in progressione del braccio A possono essere idonei all'arruolamento al completamento del protocollo UTX-TGR-304
    2. Funzionalità d’organo adeguata, definita come segue:
    a. Conta assoluta dei neutrofili (ANC) >750/conta piastrinica >40.000.
    b. Bilirubina totale =1,5 volte il limite superiore della norma (ULN)
    c. Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) =2,5 x l’ULN in assenza di coinvolgimento epatico o =5 x l’ULN in caso di coinvolgimento epatico noto
    d. Clearance della creatinina calcolata >30 ml/min (calcolata mediante formula di Cockcroft-Gault)
    3. Stato di validità secondo l’Eastern Cooperative Oncology Group (ECOG) =2
    4. Capacità di ingerire e trattenere un farmaco orale
    5. Disponibilità e capacità di attenersi alle procedure della sperimentazione e del follow-up, fornire consenso informato scritto
    E.4Principal exclusion criteria
    1. Prior treatment with obinutuzumab + chlorambucil (Arm B patients) or ublituximab (Arm C patients) within 7 days of Cycle 1/Day 1.
    2. Patients refractory to (progressing on) UTX-TGR-304 Treatment Arm A (ublituximab + TGR-1202).
    3. Known histological transformation from CLL to an aggressive lymphoma (i.e. Richter’s transformation).
    4. Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails. NOTE: Patients may be receiving prophylactic
    antiviral or antibacterial therapies at investigator discretion. Use of anti-pneumocystis prophylaxis is encouraged.
    5. Woman who are pregnant or lactating.
    1. Trattamento precedente con obinutuzumab + clorambucile (pazienti del braccio B) o ublituximab (pazienti del braccio C) entro 7 giorni dal Giorno 1 del Ciclo 1.
    2. Pazienti refrattari (in progressione) al braccio di trattamento A di UTX-TGR-304 (ublituximab + TGR-1202).
    3. Trasformazione istologica nota da LLC a linfoma aggressivo (ovvero, trasformazione di Richter).
    4. Evidenza di infezione sistemica in corso di natura batterica, fungina o virale, eccetto infezioni fungine localizzate della cute o delle unghie. NOTA: i pazienti potrebbero ricevere terapie antivirali o antibatteriche profilattiche a discrezione dello sperimentatore. Si raccomanda l'uso di una profilassi anti-pneumocisti.
    5. Donne in gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    1) Overall response rate (ORR). ORR is defined as sum of CR and PR rates. 2) Complete Response (CR) Rate. CR rate is defined as the proportion of patients who achieve a CR. 3) Progression-free survival (PFS). PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. 4) Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy, organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. 5) Duration of response (DOR). DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
    Endpoint di efficacia Tasso di risposta complessiva (ORR)
    L’ORR è definito come somma dei tassi di risposta completa (CR) e risposta parziale (PR).
    Tasso di risposta completa (CR)
    Il tasso di CR è definito come la percentuale di pazienti che ottengono una CR.
    Sopravvivenza libera da progressione (PFS)
    La PFS è definita come l’intervallo dall'arruolamento alla prima documentazione di progressione definitiva della malattia o al decesso per qualsiasi causa, a seconda di quale evento si verifica prima.
    Progressione definitiva della malattia in base ai criteri standard (Hallek et al. 2008) e verificatisi per qualsiasi ragione (ovvero, peggioramento della linfoadenopatia, dell’organomegalia o del coinvolgimento del midollo osseo; diminuzione della conta piastrinica, dell’emoglobina o della conta dei neutrofili; oppure peggioramento dei sintomi correlati alla malattia) diverso dalla linfocitosi.
    Tasso di negatività della malattia minima residua (MMR)
    Il tasso di negatività MMR è definito come la percentuale di pazienti MMR-negativi.
    Durata della risposta (DOR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated.
    Le valutazioni sono da fare seguendo i completamenti di cicli 3, 6, 9 12, 15, 18 e ogni 3 cicli. Un ciclo è di 28 giorni. I pazienti che interrompono il trattamento di studio (sia per la tossicità o la scelta del medico) e non hanno progredito continueranno ad essere seguiti per la progressione secondo lo standard di cura istituzionali o fino a quando si inizia un nuovo trattamento anti-cancro.
    E.5.2Secondary end point(s)
    1) Minimal Residual Disease (MRD) Negativity Rate. MRD negativity rate is defined as the proportion of patients who are MRD negative. 2) Progression-free survival (PFS). PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. 3) Duration of response (DOR). DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. 4) Safety evaluation
    1)Tasso di Negativit¿ di malattia minima residua (MRD). Il tasso MRD ¿ definito come la percentuale di pazienti che sono MRD negativi. 2) la sopravvivenza libera da progressione (PFS). PFS ¿ definito come l'intervallo dall¿arruolamento al primo degli eventi tra la prima documentazione di progressione della malattia definitiva o morte per qualsiasi causa. 3) La durata della risposta (DOR). DOR ¿ definito come l'intervallo dalla prima documentazione di CR o PR all¿evento che accade prima tra la documentazione di progressione della malattia definitiva o morte per qualsiasi causa. 4) Valutazione della sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point

    Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated. Safety - All AEs will be reported and evaluated using National Cancer Institute¿s Common Terminology Criteria (CTCAE) v4.0
    Le valutazioni sono ottenute seguendo i completamenti di cicli 3, 6, 9 12, 15, 18 e ogni 3 cicli. Un ciclo ¿ di 28 giorni. I pazienti che interrompono il trattamento di studio (sia per la tossicit¿ o la scelta del medico) e non hanno progredito continueranno ad essere seguiti per la progressione secondo lo standard di cura o fino a quando si inizia un nuovo trattamento anti-cancro. Sicurezza - Tutti gli eventi avversi verranno segnalati e valutati in base a criteri comuni terminologia di National Cancer Institute (CTCAE) v4.0
    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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 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 EEA45
    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
    Czech Republic
    Italy
    Poland
    Spain
    United Kingdom
    United States
    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
    Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated
    I pazienti che interrompono il trattamento di studio (sia per la tossicit¿ o la scelta del medico) e non hanno registrato progressi continueranno ad essere seguiti in standard di cura per la progressione o fino a quando si inizia un nuovo trattamento anti-cancro
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 75
    F.4.2.2In the whole clinical trial 200
    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)
    Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated.
    I pazienti che interrompono il trattamento di studio (sia per la tossicit¿ o la scelta del medico) e non hanno registrato progressi continueranno ad essere seguit secondo lo standarda di cura per la progressione o fino a quando si inizia un nuovo trattamento anti-cancro
    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 Decision2017-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-29
    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-Thu Apr 25 20:49:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA