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   43845   clinical trials with a EudraCT protocol, of which   7282   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:2011-000049-19
    Sponsor's Protocol Code Number:C11310
    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:2011-12-29
    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 number2011-000049-19
    A.3Full title of the trial
    A Phase III randomized, double-blind, placebocontrolled study with an open-label extension evaluating the efficacy, safety and immunogenicity of recombinant human C1 inhibitor for the treatment of acute attacks of angioedema in patients with HAE
    Studio di fase III randomizzato, in doppio cieco, controllato con placebo, con un'estensione open-label, volto a valutare l'efficacia, la sicurezza e l'immunogenicita' del C1-inibitore umano ricombinante per il trattamento di attacchi acuti in pazienti affetti da angioedema ereditario (HAE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase randomized, double-blind, placebocontrolled study with an open-label extension evaluating the efficacy, safety of recombinant human C1 inhibitor
    Studio randomizzato, in doppio cieco, controllato con placebo, con una estensione open-label, volto a valutare l’efficacia, la sicurezza del C1-inibitore umano ricombinante
    A.4.1Sponsor's protocol code numberC11310
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01188564
    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 SponsorPHARMING TECHNOLOGIES B.V.
    B.1.3.4CountryNetherlands
    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 supportPHARMING TECHNOLOGIES B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCMED (CLINICAL RESEARCH SERVICES) LTD
    B.5.2Functional name of contact pointELISABETTA ZUCCATO
    B.5.3 Address:
    B.5.3.1Street AddressHOLMWOOD, BROADLANDS BUSINESS CAMPUS, LANGHURSTWOOD ROAD, WEST SUSSEX
    B.5.3.2Town/ cityHORSHAM
    B.5.3.3Post codeRH12 4QP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)1403 756421
    B.5.5Fax number+44 (0) 1403 755051
    B.5.6E-mailezuccato@cmedresearch.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 Ruconest
    D.2.1.1.2Name of the Marketing Authorisation holderPharming Technologies
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNconestat alfa
    D.3.9.1CAS number 80295-38-1
    D.3.9.2Current sponsor coderhC1INH
    D.3.9.4EV Substance CodeSUB30787
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2100
    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 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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary angioedema (HAE). Hereditary angioedema (HAE). Attacks in patients with hereditary angioedema(HAE) due to C1 esterase inhibitor deficiency.
    Angioedema Ereditario (HAE). Attacchi in pazienti con Angioedema ereditario (HAE) sono dovuti alla carenza dell'esterasi C1-inibitore funzionale (C1INH).
    E.1.1.1Medical condition in easily understood language
    This disease causes repeated attacks of,sometimes serious swelling of the arms,legs,hands,feet,face and throat, abdominal cavity,and/or uro-genital region and/or other places and tissues
    Questa malattia causa attacchi ripetuti, a volte seri, di gonfiori a braccia, gambe, mani piedi, faccia, gola e cavita' addominale e/o regione uro-genitale e/o altre localizzazioni e tessuti
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 efficacy and safety of rhC1INH at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients with HAE.
    1.Valutare l’efficacia e la sicurezza di rhC1INH a un dosaggio di 50 U/kg quando usato per il trattamento di attacchi acuti di angioedema in pazienti affetti da HAE.
    E.2.2Secondary objectives of the trial
    To assess efficacy, safety and immunogenicity of rhC1INH when used for the repeat treatment of acute angioedema attacks in patients with HAE.
    valutare l’efficacia, la sicurezza e l’immunogenicita' di rhC1INH quando usato per il trattamento ripetuto di attacchi acuti di angioedema in pazienti affetti da HAE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening Inclusion Criteria: 1. Age at least 18 years 2. Signed written informed consent 3. Clear clinical and laboratory diagnosis of HAE with baseline plasma level of functional C1INH of less than 50% of normal 4. Willingness and ability to comply with all protocol procedures Inclusion Criteria for Randomized treatment: 1. Above screening criteria continue to be met 2. Clinical symptoms of HAE attack 3. Onset of symptoms at eligible attack location (abdominal, peripheral, facial, or oropharyngeal-laryngeal) less than 5 hours before the time at which initial evaluation determined eligibility for inclusion 4. ‘Overall severity VAS’ score for at least one anatomical location at the time of initial evaluation and Time 0 is at least 50 mm 5. No evidence of regression of angioedema symptoms scored with VAS at t = 0 h compared with VAS score at the time of initial evaluation, i.e. no decrease in symptoms of angioedema scored with overall VAS at t = 0 h compared with score at the time of initial evaluation by 20 mm or more at the primary attack location. Inclusion Criteria for Open Label Treatment for subsequent angioedema attacks: 1. Above screening and randomization criteria continue to be met for subsequent eligible attack. (Any anatomical location of HAE attack, including urogenital, may be treated in the open-label phase of the study provided it meets the other criteria stated above with respect to onset, severity, and lack of regression.) 2. 24 hours have passed since the patient’s randomized or last open-label treatment.
    Criteri di inclusione allo screening: 1. Eta' minima del paziente: 18 anni 2. Firma del consenso informato scritto 3. Chiara diagnosi clinica e di laboratorio di HAE con livello di plasma al basale di C1INH funzionale inferiore al 50% del normale 4. Disponibilita' e capacita' di attenersi alle procedure previste dal protocollo. Criteri di inclusione per il trattamento randomizzato: 1. I suddetti criteri di inclusione applicati allo screening continuano ad essere soddisfatti 2. Sintomi clinici di attacco di HAE 3. Insorgenza dei sintomi in una posizione idonea dell’attacco (addominale, periferica, facciale o orofaringea e laringea) a meno di 5 ore dal momento in cui la valutazione iniziale ha determinato l’idoneita' per l’inclusione 4. Il punteggio su “VAS della gravita' complessiva” per almeno una posizione anatomica al momento della valutazione iniziale e a Tempo 0 e' di almeno 50 mm 5. Nessuna evidenza di regressione dei sintomi di angioedema con punteggio su VAS a t = 0 confrontato con punteggio su VAS al momento della valutazione iniziale, cioe' nessuna diminuzione nel punteggio dei sintomi di angioedema su VAS complessiva a t = 0 confrontato con il punteggio assegnato al momento della valutazione iniziale pari a 20 mm o superiore nella posizione principale dell’attacco. Criteri di inclusione per il trattamento in aperto per gli attacchi successivi di angioedema: 1. I suddetti criteri per screening e randomizzazione continuano ad essere soddisfatti per i successivi attacchi idonei. (Qualsiasi posizione anatomica di un attacco di HAE, inclusa quella urogenitale, puo' essere trattata nella fase in aperto dello studio se soddisfa gli altri suddetti criteri relativi all’insorgenza, alla gravita' e alla mancanza di regressione.) 2. Sono trascorse 24 ore dal trattamento randomizzato o dall’ultimo open-label del paziente.
    E.4Principal exclusion criteria
    Exclusion Criteria at Screening: 1. Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH), or positive anti-rabbit epithelium (dander) IgE test (cut off >0.35 kU/L; ImmunoCap® assay; Phadia or equivalent). 2. A diagnosis of acquired C1INH deficiency (AAE) 3. Pregnancy, or breastfeeding, or current intention to become pregnant 4. Treatment with any investigational drug in the past 30 days 5. Any clinically significant abnormality in the study-specific hematology, biochemistry that, in the opinion of the investigator, might interfere with the evaluation of study objectives 6. Any condition or treatment that, in the opinion of the investigator, might interfere with the evaluation of study objectives 7. Known or suspected addiction to drug and/or alcohol abuse Exclusion Criteria for Randomized treatment: 1. Any changes since screening that would exclude patient based on above exclusion criteria 2. Suspicion for an alternate explanation of the symptoms other than acute HAE attack 3. Blood in urine (for patients with abdominal symptoms only) 4. Blood in stool (for patients with abdominal symptoms only) 5. Fever (oral temp > 38° C) 6. Positive pregnancy test (urine or serum). Patients with life-threatening symptoms (e.g. a laryngeal attack with respiratory and/or cardiovascular compromise) should be immediately treated with any medication or procedure (including intubation, tracheostomy) deemed necessary and effective treatment should not be postponed because of randomization procedures or possibility of being randomized to placebo. Exclusion Criteria for Open label Treatment: 1. Any changes since screening that would exclude subject based on above exclusion criteria. 2. Suspicion for an alternate explanation of the symptoms other than acute HAE attack 3. Blood in urine (for patients with abdominal symptoms only) 4. Blood in stool (for patients with abdominal symptoms only) 5. Fever (oral temp > 38° C) 6. Positive pregnancy test (urine or serum). 7. Positive anti-rabbit epithelium (dander) IgE test (cut off >0.35 kU/L; ImmunoCap assay; Phadia or equivalent)(performed at a previous D28 visit)
    Criteri di esclusione allo screening: 1. Anamnesi di allergia ai conigli o a prodotti derivati da conigli (incluso rhC1INH) o esame positivo delle IgE contro l’epitelio del coniglio (dander) (cut-off &gt;0,35 kU/l; esame ImmunoCap; Phadia o equivalente). 2. Una diagnosi di deficit di C1INH acquisito (AAE) 3. Gravidanza, allattamento al seno o intenzione di intraprendere una gravidanza 4. Trattamento con qualsiasi farmaco sperimentale negli ultimi 30 giorni 5. Qualsiasi anomalia clinica significativa nell’ematologia e biochimica specifiche dello studio che, a parere dello sperimentatore, possa interferire con la valutazione degli obiettivi dello studio 6. Qualsiasi condizione o trattamento che, a parere dello sperimentatore, possa interferire con la valutazione degli obiettivi dello studio 7. Dipendenza o sospetto di dipendenza da droghe e/o abuso di alcol. Criteri di esclusione per il trattamento randomizzato: 1. Qualsiasi cambiamento dallo screening che escluderebbe il paziente sulla base dei suddetti criteri di esclusione 2. Sospetto di una spiegazione alternativa dei sintomi rispetto a quella di un attacco acuto di HAE 3. Sangue nelle urine (per i pazienti solo con sintomi addominali) 4. Sangue nelle feci (per i pazienti solo con sintomi addominali) 5. Febbre (temperatura orale &gt; 38° C) 6. Test di gravidanza positivo (su urina o siero). Criteri di esclusione per il trattamento in aperto: 1. Qualsiasi cambiamento dallo screening che escluderebbe il paziente sulla base dei suddetti criteri di esclusione 2. Sospetto di una spiegazione alternativa dei sintomi rispetto a quella di un attacco acuto di HAE 3. Sangue nelle urine (per i pazienti solo con sintomi addominali) 4. Sangue nelle feci (per i pazienti solo con sintomi addominali) 5. Febbre (temperatura orale &gt; 38° C) 6. Test di gravidanza positivo (su urina o siero). 7. Esame positivo delle IgE contro l’epitelio del coniglio (dander) (cut-off &gt;0,35 kU/l; esame ImmunoCap Phadia o equivalente) (eseguito durante una visita precedente al Giorno 28).
    E.5 End points
    E.5.1Primary end point(s)
    • Primary efficacy variable: Time to beginning of relief at the primary attack location, defined as the time between beginning of treatment administration and the first time point at which: o The patient reports the following answers for TEQ Question 1: “A little better”, Better” or “Much better; and, o The patient reports the following answer for TEQ Question 2: “Yes”; and, o There is persistence of improvement at the next assessment time, i.e., either the same or a better response to Question 1 and “Yes” to Question 2).
    • Variabile di efficacia primaria: il tempo fino all’inizio della percezione di sollievo, alla posizione principale dell’attacco, definito come il tempo tra l’inizio della somministrazione del farmaco dello studio e il primo punto temporale durante il quale: • Il paziente riporta la seguente risposta alla domanda 1 del TEQ:“Un pochino meglio”, “Meglio”, o “Molto meglio”; e, • Il paziente riporta la seguente risposta alla domanda 2 del TEQ: “si'”, e, • Vi e' persistenza del miglioramento al successivo momento di valutazione, ovvero, o la stessa o una risposta migliore alla domanda 1 e “si'” alla domanda 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be assessed by TEQ for each symptomatic anatomical location at the following time points: 0 (just before study medication administration), 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 2, 2 ½ , 3, 3 ½, 4, 4 ½, 5, 5 ½, and 6 hours.
    L`Obiettivo primario sara' valutato dalla misurazione del TEQ per ogni localizzazione sintomatica ai seguenti timepoint: 0 (subito prima della somministrazione del farmaco in studio) 15 min, 30 min, 45 min, 60 min, 90 min, 2 ore, 2,5 ore, 3 ore, 3,5 ore, 4 ore, 4,5 ore, 5 ore, 5,5 ore e 6 ore
    E.5.2Secondary end point(s)
    Secondary efficacy variable: Time to minimal symptoms defined as the time between beginning of treatment administration and the first time point at which the patient provides an affirmative response to Question 3 of the TEQ at all symptomatic locations
    • Variabile di efficacia secondaria: il tempo ai sintomi minimi definito come il tempo tra l’inizio della somministrazione del farmaco dello studio e il primo punto temporale durante il quale il paziente fornisce una risposta affermativa alla domanda 3 del TEQ in tutte le posizioni sintomatiche.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end point will be assessed by TEQ for each symptomatic anatomical location at the following time points: 0 (just before study medication administration), 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 2, 2 ½ , 3, 3 ½, 4, 4 ½, 5, 5 ½, and 6 hours.
    L`Obiettivo secondario sara' valutato dalla misurazione del TEQ per ogni localizzazione sintomatica ai seguenti timepoint: 0 (subito prima della somministrazione del farmaco in studio) 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 2 ore, 2,5 ore, 3 ore, 3,5 ore, 4 ore, 4,5 ore, 5 ore, 5,5 ore e 6 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 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 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 Yes
    E.8.1.7.1Other trial design description
    CON UNA FASE DI ESTENSIONE IN APERTO
    with Open Label Extension Phase
    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 No
    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 EEA6
    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 No
    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
    Macedonia, the former Yugoslav Republic of
    South Africa
    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
    The study will end after approximately 75 patients receive randomized treatment and the Sponsor determines sufficient data have been collected on repeat treatments in the open label extension phase (OLE).
    Lo studio si concludera' dopo che circa 75 pazienti riceveranno un trattamento randomizzato e lo Sponsor determinera' che siano stati raccolti sufficienti dati sui trattamenti ripetuti nella fase in aperto (OLE)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1Number of subjects for this age range: 0
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 30
    F.4.2.2In the whole clinical trial 75
    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)
    According to current guidelines for the disease.
    In accordo alle linee guida correnti per la patologia.
    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 Decision2011-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-07
    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 Apr 19 07:23:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA