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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2017-004902-16
    Sponsor's Protocol Code Number:Nef-301
    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:2021-01-20
    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 number2017-004902-16
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd).
    Studio randomizzato, in doppio cieco, controllato verso placebo, per valutare l’efficacia e la sicurezza di Nefecon in pazienti affetti da nefropatia da IgA primaria a rischio di progressione verso la malattia renale terminale (NefIgArd)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.
    Uno studio nel quale la sicurezza e l'efficacia di Nefecon sono confrontate con placebo in pazienti con nefropatia IgA primaria.
    A.3.2Name or abbreviated title of the trial where available
    A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primar
    Uno studio nel quale la sicurezza e l'efficacia di Nefecon sono confrontate con placebo in pazienti
    A.4.1Sponsor's protocol code numberNef-301
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorCALLIDITAS THERAPEUTICS AB
    B.1.3.4CountrySweden
    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 supportCalliditas Therapeutics AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCalliditas Therapeutics AB
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressKungsbron 1
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-111 22
    B.5.3.4CountrySweden
    B.5.4Telephone number0046763949872
    B.5.5Fax number0123456
    B.5.6E-mailfredrik.juhlin@calliditas.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/139/16 (EMA/COMP/513517/2016)
    D.3 Description of the IMP
    D.3.1Product nameNefecon
    D.3.2Product code [Nefecon]
    D.3.4Pharmaceutical form Modified-release 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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary IgA nephropathy patients at risk of developing end stage renal disease
    Trattamento della nefropatia da immunoglobuline A (Immunoglobulin A Nephropathy, IgAN) primaria
    E.1.1.1Medical condition in easily understood language
    Patients with kidney diseases that have damage to the kidneys associated with Immunoglobulin A
    Pazienti con patologie renali che hanno danno ai reni associato con Immunoglobulina A
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10069341
    E.1.2Term Berger's disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    The primary objective of Part A is to assess the effect of Nefecon 16 mg treatment on urine protein to creatinine ratio (UPCR) over 9 months compared to placebo.
    Part B:
    The primary objective of Part B is to assess the effect of the Nefecon 16 mg treatment given in Part A on clinical consequences of any proteinuria reduction as measured by estimated glomerular filtration rate (eGFR) recorded over 2 years compared to placebo.
    Parte A
    L’obiettivo primario della Parte A è valutare l’effetto del trattamento con Nefecon 16 mg sul rapporto urinario proteine/creatinina (Urine Protein To Creatinine Ratio, UPCR) nell’arco di 9 mesi rispetto a placebo.
    Parte B
    L’obiettivo primario della Parte B è valutare l’effetto del trattamento con Nefecon 16 mg somministrato nella Parte A sulle conseguenze cliniche di qualsiasi riduzione della proteinuria, come misurato dalla velocità di filtrazione glomerulare stimata (estimated Glomerular Filtration Rate, eGFR) registrata nell’arco di 2 anni, rispetto a placebo.
    E.2.2Secondary objectives of the trial
    Part A:
    The secondary objectives of Part A are:
    • To assess the effect of Nefecon 16 mg treatment on eGFR at 9 and 12 months compared to placebo, and
    • To evaluate additional aspects of renal function, and safety and tolerability of Nefecon 16 mg treatment over 9 months compared to placebo.
    Part B:
    The secondary objectives of Part B are to assess the effects of the Nefecon 16 mg treatment given in Part A on different aspects of renal function and safety compared to placebo over 2 years.
    Parte A
    Gli obiettivi secondari della Parte A consistono nel:
    • valutare l’effetto del trattamento con Nefecon 16 mg sull’eGFR a 9 e 12 mesi rispetto al placebo, e
    • valutare altri aspetti della funzione renale, nonché della sicurezza e tollerabilità del trattamento con Nefecon 16 mg nell’arco di 9 mesi rispetto a placebo.
    Parte B
    Gli obiettivi secondari della Parte B consistono nel valutare gli effetti del trattamento con Nefecon 16 mg somministrato nella Parte A su aspetti diversi della funzione renale, nonché la sicurezza rispetto a placebo nell’arco di 2 anni.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria at screening to be eligible for admission into the study:
    1. Female or male patients =18 years of age;
    2. Diagnosed IgAN with biopsy verification within the past 10 years;
    3. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or MTD according to the 2012 KDIGO guidelines for the 3 months prior to randomization (see Appendix D). In this instance, a stable dose is defined as doses within 25% of the dose at randomization. Patients on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) below the maximum allowed dose or MTD according to the 2012 KDIGO guidelines will be permitted into the study if an attempt to reach the maximum allowed dose or MTD has been performed21 or if
    such attempt is deemed unsafe for the patient by the Investigator; and Note: It is recommended that patients achieve a target systolic blood pressure <125 mmHg and target diastolic blood pressure <75 mmHg according to the 2012 KDIGO guidelines.
    4. Willing and able to provide written informed consent at screening. In addition, patients must meet the following inclusion criteria before randomization into the study:
    5. Proteinuria based on 2 consecutive measurements (24-hour urine sampling) after informed consent, separated by at least 2 weeks and calculated by the central laboratory. Both samples of the same parameter must show either of the following:
    o Proteinuria =1 g per day (=1000 mg per day) in 2 consecutive
    measurements, or
    o UPCR =0.8 g/gram (=90 mg/mmol) in 2 consecutive measurements; and
    6. eGFR >=35 mL/min per 1.73 m2 and =90 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, confirmed by the central laboratory at Study Visit 1 or Study Visit 3.
    I pazienti devono soddisfare tutti i seguenti criteri di inclusione allo screening per essere ammessi nello studio:
    1. Pazienti di sesso femminile o maschile di 18 anni;
    2. IgAN diagnosticata con verifica della biopsia negli ultimi 10 anni;
    3. in dose stabile di terapia con inibitori della RAS (ACEI e / o ARB) alla dose massima consentita o MTD secondo le linee guida KDIGO 2012 per i 3 mesi precedenti la randomizzazione (fare riferimento ad Appendice D). In questo caso, una dose stabile è definita come dosi entro il 25% della dose al momento della randomizzazione. I pazienti che assumono una dose stabile di terapia con inibitori della RAS (ACEI e / o ARB) al di sotto della dose massima consentita o MTD secondo le linee guida KDIGO 2012 saranno ammessi allo studio se è stato eseguito un tentativo di raggiungere la dose massima consentita o MTD21 o Se tale tentativo è ritenuto non sicuro per il paziente dall'Investigatore; e Nota: si raccomanda ai pazienti di raggiungere una pressione arteriosa sistolica target <125 mmHg e una pressione arteriosa diastolica target <75 mmHg secondo le linee guida KDIGO del 2012.
    4. Disposti e in grado di fornire il consenso informato scritto allo screening.
    Inoltre, i pazienti devono soddisfare i seguenti criteri di inclusione prima della randomizzazione nello studio:
    5. Proteinuria basata su 2 misurazioni consecutive (sulla base del campionamento urinario delle 24 ore) dopo consenso informato, separate da almeno 2 settimane e calcolate dal laboratorio centrale. Entrambi i campioni dello stesso parametro devono mostrare uno dei seguenti:
    - Proteinuria >= 1 g al giorno, o
    - UPCR >= 0,8 g / grammo (=90 mg/mmol) in due misure consecutive; e
    6. eGFR >= 35 mL / min per 1,73 m2 e 90 mL / min per 1,73 m2 utilizzando la formula di Cronic Kidney Disease Epidemiology Collaboration (CKD-EPI), confermata dal laboratorio centrale alla Visita di Studio 1 o Visita di Studio 3.
    E.4Principal exclusion criteria
    Please refer to the protocol due to characters number limitation
    A causa di limitazione del numero di caratteri si prega di far riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the Part A analysis is defined as the ratio of UPCR (based on 24 hour urine collections) at 9 months following the first dose of study drug compared to baseline. The primary efficacy endpoint for the Part B analysis is an area under the curve (AUC)-based endpoint of eGFR calculated as a time-weighted average of eGFR recordings observed at each time point over 2 years. The eGFR (CKD EPI) at 2 years (which must be repeated by a second value obtained within 14 to 35 days) will be the geometric mean of the 2 assessments.
    L'endpoint primario di efficacia per l'analisi della parte A è definito come il rapporto di UPCR (basato su raccolte di urine nelle 24 ore) a 9 mesi dopo la prima dose del farmaco in studio rispetto al basale. L'endpoint primario di efficacia per l'analisi della parte B è un'area sotto endpoint della curva di eGFR basata su curva (AUC) calcolata come media ponderata nel tempo delle registrazioni di eGFR osservate in ciascun punto temporale nell'arco di 2 anni. L'eGFR (CKD EPI) a 2 anni (che deve essere ripetuto da un secondo valore ottenuto entro 14-35 giorni) sarà la media geometrica delle 2 valutazioni.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data analysis will include the first 200 patients randomized. The data cut-off for the Part A analysis will occur 9.5 months after the 200th patient randomized is dosed (or, if the 200th patient randomized does not receive any study drug, 9.5 months after the 200th patient is randomized). Supportive analyses of the above endpoints will also be performed at other time points to describe the time course of effect. The Part B analysis will be performed when the 360th/last patient randomized has been followed for 25 months after the first dose (or, if the 360th/last patient randomized does not receive any study drug, 25 months after the 360th/last patient is randomized). At the time of the Part B analysis, the Part A analysis will be repeated using all patients randomized.
    L'analisi dei dati includerà i primi 200 pazienti random. Il cut-off dei dati per l'analisi della Parte A avverrà 9,5 mesi dopo la somministrazione del paziente 200 random (o, se il paziente 200 random non riceve alcun farmaco in studio, 9,5 mesi dopo il paziente 200 random). Analisi di supporto degli endpoint sopra verranno eseguite anche in altri punti temporali per descrivere l'andamento temporale dell'effetto. L'analisi della parte B verrà eseguita quando il 360/ultimo paziente randomizzato è stato seguito per 25 mesi dopo la prima dose (o, se il 360/ultimo paziente randomizzato non riceve alcun farmaco in studio, 25 mesi dopo il 360/ultimo paziente è randomizzato). Al momento dell'analisi della parte B, l'analisi della parte A verrà ripetuta utilizzando tutti i pazienti randomizzati.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints for the Part A analysis are:
    • Ratio of eGFR at 9 and 12 months compared to baseline calculated using the CKD-EPI formula, and
    • Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline.
    The secondary efficacy endpoints for the Part B analysis are:
    • Time to 30% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value, with 4 weeks of separation between the 2 sampling time points;
    • Time from the first dose of study drug until receiving rescue medication;
    • Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug;
    • Proportion of patients without microhematuria in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug;
    • Proportion of patients receiving rescue treatment; and • Short Form 36 (SF-36) quality of life assessment at 9 and 24 months.; Gli endpoint secondari di efficacia per l'analisi della parte A sono:
    • Rapporto tra eGFR a 9 e 12 mesi rispetto al basale calcolato utilizzando la formula CKD-EPI e
    • Rapporto tra albumina urinaria e rapporto creatinina (UACR) a 9 mesi rispetto al basale.
    Gli endpoint secondari di efficacia per l'analisi della parte B sono:
    • Riduzione del tempo al 30% dal basale in eGFR (CKD-EPI) confermata da un secondo valore, con 4 settimane di separazione tra i 2 punti del tempo di campionamento;
    • Tempo trascorso dalla prima dose del farmaco in studio fino alla ricezione del farmaco di salvataggio;
    • Rapporto tra UPCR, UACR ed eGFR (CKD-EPI) rispetto al basale mediato su punti temporali tra 12 e 24 mesi, incluso, dopo la prima dose del farmaco in studio;
    • Proporzione di pazienti senza microematuria in almeno 2 dei seguenti punti temporali: 12, 18 e 24 mesi dopo la prima dose del farmaco in studio;
    • percentuale di pazienti sottoposti a terapia di salvataggio; e • Short Form 36 (SF-36) valutazione della qualità della vita a 9 e 24 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are described within the text in section E.5.1.1
    Il tempo di rilevazione è descritto nel testo alla sezione E.5.1.1
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Argentina
    Australia
    Belarus
    Canada
    China
    Korea, Republic of
    Taiwan
    Turkey
    Belgium
    Czechia
    Finland
    France
    Germany
    Greece
    Italy
    Poland
    Spain
    Sweden
    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
    The end of the study is defined as the date of the last subject's last visit.
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days26
    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: 328
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 360
    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 Decision2018-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Sat Apr 27 02:54:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA