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:2016-000374-37
    Sponsor's Protocol Code Number:161505
    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:2021-06-17
    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 number2016-000374-37
    A.3Full title of the trial
    Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
    Tollerabilit¿ e sicurezza a lungo termine dell¿infusione di immunoglobulina (umana) al 10% con ialuronidasi umana ricombinante (HYQVIA/HyQvia) per il trattamento della poliradiculoneuropatia demielinizzante infiammatoria cronica (CIDP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD
    Tollerabilit¿ e sicurezza a lungo termine di HYQVIA/HyQvia in CIDP
    A.3.2Name or abbreviated title of the trial where available
    Long-Term Tolerability and Safety of HYQVIA/HyQviain CIPD
    Tollerabilit¿ e sicurezza a lungo termine di HYQVIA/HyQvia in CIDP
    A.4.1Sponsor's protocol code number161505
    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 SponsorBAXALTA INNOVATIONS GMBH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovation GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta Innovation GmbH
    B.5.2Functional name of contact pointAndras Nagy
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 67
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+4301201002476725
    B.5.5Fax number+4301201002475727
    B.5.6E-mailandras.nagy@shire.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HyQvia 100 mg/ml solution for infusion for subcutaneous use
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHyQvia
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMMUNOGLOBULINA UMANA NORMALE
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameHuman normal immunoglobulin
    D.3.9.4EV Substance CodeSUB14196MIG
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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 inflammatory demyelinating polyradiculoneuropathy
    Poliradiculoneuropatia demielinizzante infiammatoria cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Inflammatory Demyelinating Polyneuropathy is a rare disorder
    of the peripheral nerves (nerves outside the central nervous system)
    caused by damage to the covering of the nerves called myelin
    La Poliradiculoneuropatia demielinizzante infiammatoria cronica è una malattia rara
    dei nervi periferici causato da danni al rivestimento dei nervi chiamato mielina
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous 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
    To evaluate the long-term safety, tolerability, and immunogenicity of HYQVIA/HyQvia.
    Valutare la sicurezza, la tollerabilit¿ e l¿immunogenicit¿ a lungo termine di HYQVIA/HyQvia
    E.2.2Secondary objectives of the trial
    To assess the long-term effect of HYQVIA/HyQvia on clinical outcome measures, including prevention of relapse, change in functional ability, hand grip strength, and muscle strength.
    To assess the long-term effect of HYQVIA/HyQvia on quality of life, health utility, health resource utilization (HRU), treatment satisfaction, treatment preference, and subject global impression of change.
    To explore further the pharmacokinetics of HYQVIA/HyQvia in CIDP subjects.
    Valutare gli effetti a lungo termine di HYQVIA/HyQvia sulle misure di esiti clinici, compresa la prevenzione delle recidive e i cambiamenti nella capacit¿ funzionale, nella forza di presa della mano e nella forza muscolare.
    Valutare l¿effetto a lungo termine di HYQVIA/HyQvia sulla qualit¿ di vita, sui costi/benefici riguardanti la salute, sull¿utilizzo delle risorse sanitarie (HRU), sulla soddisfazione riguardo al trattamento, sulla preferenza di trattamento e sull¿impressione globale di cambiamento del soggetto.
    Studiare ulteriormente la farmacocinetica di HYQVIA/HyQvia nei soggetti con CIDP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    They completed Phase 1 of the 161403 study or study 161601 without showing any worsening in the CIDP.
    In the case of fertile woman, the subject must have a negative pregnancy test at the baseline visit and agree to take appropriate birth control measures (for example, contraceptive pills / plasters, intrauterine devices [IUD] or diaphragms or condoms [for the partner ] with gel or spermicidal foam) for the entire duration of the study.
    Hanno completato la Fase 1 dello studio 161403 o lo studio 161601 senza mostrare peggioramenti nella CIDP.
    Nel caso di donna fertile, il soggetto deve avere un test di gravidanza negativo alla visita basale e accettare di adottare adeguate misure di controllo delle nascite (ad esempio, pillole/cerotti anticoncezionali, dispositivi intrauterini [IUD] o diaframmi oppure preservativi [per il compagno] con gel o schiuma spermicida) per l’intera durata dello studio.
    E.4Principal exclusion criteria
    The subject has a serious medical condition such that, in the opinion of the investigator, participation in this extension study would have repercussions on the patient's safety or medical care.
    A new medical condition that developed during participation in the 161403 study or in the 161601 study which, according to the investigator's judgment, could increase the risks to the subject or interfere with the evaluation of the experimental medicinal product and / or the
    conducting the study.
    The subject is expected to participate in another non-Baxalta clinical trial that provides an IP or an experimental device during the course of the present study.
    The subject breastfeeds or intends to start breastfeeding during the course of the study.
    The subject has already participated in another clinical trial that included the use of an IP or an experimental device within 30 days prior to enrollment or planned to participate in another clinical trial (with the exception of protocol 161403 or protocol 161601). ) which foresees the use of an IP or an experimental device during the course of the present study.
    The subject is a family member or an employee of the experimenter.
    Il soggetto presenta una condizione medica grave tale che, secondo l’opinione dello sperimentatore, la partecipazione a questo studio di estensione si ripercuoterebbe sulla sicurezza o sulle cure mediche del soggetto.
    Una nuova condizione medica che si è sviluppata durante la partecipazione allo studio 161403 o allo studio 161601 che, secondo il giudizio dello sperimentatore, potrebbe aumentare i rischi per il soggetto o interferire con la valutazione del medicinale sperimentale e/o con la
    conduzione dello studio.
    È previsto che il soggetto partecipi a un altro studio clinico non Baxalta che prevede un IP o un dispositivo sperimentale durante lo svolgimento del presente studio.
    Il soggetto allatta o intende iniziare l’allattamento durante il corso dello studio.
    Il soggetto ha già partecipato ad un altro studio clinico che prevedeva l’impiego di un IP o di un dispositivo sperimentale nei 30 giorni precedenti l’arruolamento o ha programmato di partecipare a un altro studio clinico (ad eccezione del protocollo 161403 o del protocollo 161601) che prevede l’uso di un IP o un dispositivo sperimentale durante il corso del presente studio.
    Il soggetto è un familiare o un dipendente dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Safety/Tolerability
    Number (percentage) of subjects experiencing any treatment-emergent
    serious and/or non-serious adverse events (SAEs and/or AEs,
    respectively), regardless of causality
    Number (percentage) of subjects experiencing causally related SAEs
    and/or AEs
    Number (percentage) of subjects with serious and/or non-serious
    adverse reactions (ARs) plus suspected ARs
    Rate of AEs that may be a result of immune-mediated response to either
    immunoglobulin,rHuPH20, or other factors as listed in Table 12-1,
    expressed as number of events per infusion and per subject-year
    Number (percentage) of infusions associated with treatment-emergent
    SAEs and/or AEs, regardless of causality
    Number (percentage) of infusions associated with causally related SAEs
    and/or AEs
    Number (percentage) of infusions temporally associated with AEs
    (defined as AEs
    occurring during or within 72 hours after completion of an infusion)
    Number (percentage) of infusions associated with serious and/or nonserious
    ARs plus suspected ARs
    Number (percentage) of infusions associated with 1 or more systemic
    AEs
    Number (percentage) of infusions associated with 1 or more local
    infusion site reactions
    Number and proportion of infusions for which the infusion rate was
    reduced and/or the infusion was interrupted or stopped due to
    intolerability and/or AEs
    Rates of systemic and local AEs, regardless of causality, expressed as
    number of events per infusion, per subject, and per subject-year
    Rates of causally related systemic and local AEs, expressed as number of
    events per infusion, per subject, and per subject-year
    Rates of systemic and local ARs plus suspected ARs, expressed as
    number of events per infusion, per subject, and per subject-year
    Number of subjects with AE(s) that led to discontinuation from study
    Number and rate per infusion of moderate or severe AEs that may be a
    result of immune mediated response to either immunoglobulin, rHuPH20
    or other factors
    Immunogenicity
    Incidence of binding antibodies to rHuPH20
    Incidence of neutralizing antibodies to rHuPH20
    Number of subjects with a decline of anti-rHuPH20 antibody titers to the
    antibody titer level at baseline in clinical study 161403 and/or to <160
    at the study completion or early discontinuation For subjects who have >10,000 titer of binding antibodies to rHuPH20:
    neutralizing antibodies and cross reactivity with Hyal-1,2 and 4
    Sicurezza/tollerabilità
    Numero (percentuale) di soggetti che manifestano qualsiasi evento avverso serio e/o evento avverso non serio (rispettivamente, SAE e/o EA) emergente dal trattamento, indipendentemente dalla causalità
    Numero (percentuale) di soggetti che manifestano SAE e/o EA casualmente correlati
    Numero (percentuale) di soggetti con reazioni avverse (RA) serie e/o non serie in aggiunta a RA sospette
    Tasso di EA che potrebbero essere dovuti a una risposta immuno-mediata a immunoglobulina, rHuPH20 o altri fattori elencati nella Tabella 12-1, espresso come numero di eventi per infusione e per anno-soggetto
    Numero (percentuale) di infusioni associate a SAE e/o EA emergenti dal trattamento, indipendentemente dalla casualità
    Numero (percentuale) di infusioni associate a SAE e/o EA correlati alla casualità
    Numero (percentuale) di infusioni temporaneamente associate ad EA (definiti come EA che si verificano durante o entro 72 ore dopo il completamento dell’infusione)
    Numero (percentuale) di infusioni associate a RA serie e/o non serie in aggiunta a RA sospette
    Numero (percentuale) di infusioni associate a 1 o più EA sistemici
    Numero (percentuale) di infusioni associate a 1 o più reazioni locali al sito di infusione
    Numero e percentuale di infusioni per cui la velocità di infusione è stata ridotta e/o l’infusione è stata sospesa o interrotta a causa di intollerabilità e/o EA
    Tassi di EA sistemici e locali, indipendentemente dalla casualità, espressi come numero di eventi per infusione, per soggetto e per anno-soggetto
    Tassi di EA sistemici e locali correlati alla causalità, espressi come numero di eventi per infusione, per soggetto e per anno-soggetto
    Tassi di RA sistemiche e locali in aggiunta a RA sospette, espressi come numero di eventi per infusione, per soggetto e per anno-soggetto
    Numero di soggetti con uno o più EA che hanno determinato l’interruzione dello studio
    Numero e tasso per infusione di EA moderati o gravi che potrebbero risultare da una risposta immuno-mediata a immunoglobulina, rHuPH20 o altri fattori
    Immunogenicità
    Incidenza di anticorpi che legano rHuPH20
    Incidenza di anticorpi neutralizzanti diretti contro rHuPH20
    Numero di soggetti che mostrano una diminuzione dei titoli anticorpali anti-rHuPH20 rispetto al livello del titolo anticorpale al basale nello studio clinico 161403 e/o <160 alla conclusione dello studio o all’interruzione anticipata
    Per i soggetti che hanno un titolo di anticorpi leganti rHuPH20 >10.000: anticorpi neutralizzanti e reattività incrociata con l’enzima ialuronidasi 1, 2 e 4 (Hyal-1, 2 e 4)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 96
    Settimana 96
    E.5.2Secondary end point(s)
    Outcome measures
    Efficacy measures
    Proportion subjects who relapse
    EuroQoL
    HRU
    Treatment satisfaction
    Treatment preference
    Misure degli esiti
    Esiti di efficacia
    Proporzione dei soggetti con recidiva
    EuroQoL
    HRU
    Soddisfazione riguardo al trattamento
    Preferenza di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetics
    Timepoints: Week 1, 2, 13, 26, 39, 52, 65, 78, 91, 104
    Efficacy measures
    Timepoints: Week 13, 26, 39, 52, 65, 78, 91, 104
    EuroQoL
    Timepoints: Baseline, week 26, 52, 78
    HRU
    Timepoints: Baseline, Week 13, 26, 39, 52, 65,78, 91, 104
    Treatment satisfaction
    Timepoints: Baseline, week 26, 52, 78
    Treatment preference
    Timepoints: Baseline, week 26, 52, 78
    Farmacocinetica
    Tempi di rilevazione : Settimana 1, 2, 13, 26, 39, 52, 65, 78, 91, 104
    Misure di efficacia
    Tempi di rilevazione : Settimana 13, 26, 39, 52, 65, 78, 91, 104
    EuroQoL
    Tempi di rilevazione : Baseline, settimane 26, 52, 78
    HRU
    Tempi di rilevazione : Baseline, settimane 13, 26, 39, 52, 65,78, 91, 104
    Soddisfazione del trattamento
    Tempi di rilevazione : Baseline, settimana 26, 52, 78
    Preferenze di trattamento
    Tempi di rilevazione : Baseline, settimana 26, 52, 78
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    immunigenicit¿
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Canada
    Colombia
    Israel
    Mexico
    Serbia
    Turkey
    Denmark
    France
    Germany
    Greece
    Italy
    Norway
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    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
    Each subject will have the opportunity to receive HYQVIA / HyQvia for a maximum of 2.5 years or up to 3 years if required by law
    Ciascun soggetto avrà l’opportunità di ricevere HYQVIA/HyQvia per un massimo di 2,5 anni o fino a 3 anni se richiesto dalle normative
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 149
    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 Care of Treatment
    Standard terapeutico di trattamento
    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 Decision2016-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-02
    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 May 02 01:57:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA