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    Summary
    EudraCT Number:2011-002462-20
    Sponsor's Protocol Code Number:KPT4-01/2011
    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:2012-03-08
    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 number2011-002462-20
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis
    Studio clinico prospettico, randomizzato, doppio cieco, controllato verso placebo per valutare l'efficacia e la sicurezza di K(D)PT in pazienti affetti da colite ulcerosa lieve-moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.
    Studio clinico prospettico, dove i pazienti assumono o il farmaco in studio o un farmaco non attivo chiamato placebo senza sapere quale dei due farmaci viene assunto; nemmeno il medico sperimentatore e' a conoscenza della terapia assunta dal paziente. I pazienti vengono assegnati ad uno specifico trattamento in base ad una lista di randomizzazione, cioe' casuale, per valutare l'effetto e la tollerabilita' del K(D)PT nella colite ulcerosa.
    A.3.2Name or abbreviated title of the trial where available
    K(D)PT in ulcerative colitis:PoC study
    Studio Pilota: K(D)PT nella colite ulcerosa
    A.4.1Sponsor's protocol code numberKPT4-01/2011
    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 SponsorDR. AUGUST WOLFF GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportDR. AUGUST WOLFF GMBH & CO. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRicerche Nuove Srl
    B.5.2Functional name of contact pointSegreteria Scientifica
    B.5.3 Address:
    B.5.3.1Street Addressvia Giuntini 63 Int. A/3
    B.5.3.2Town/ cityNavacchio (Pisa)
    B.5.3.3Post code56023
    B.5.3.4CountryItaly
    B.5.4Telephone number050754285
    B.5.5Fax number050754287
    B.5.6E-mailinfo@ricerchenuove.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLysine-D-proline-threonine
    D.3.2Product code K(D)PT
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeK(D)PT
    D.3.9.3Other descriptive nameL-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGranules for oral solution
    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
    mild to moderate ulcerative colitis
    Colite ulcerosa lieve-moderata
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis (UC) is an chronic inflammatory disease of the colon with clinical symptoms of rectal bleeding and diarrhoea
    malattia infiammatoria dell'intestino caratterizzata da diarrea e sanguinamento
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the time to response to K(D)PT, defined as the time from Day 0 to the earliest treatment visit at which a sustained improvement in CAI of ≥50% is determined (CAI scored according to Rachmilewitz, 1989)
    L'obiettivo principale è di determinare il tempo di risposta al K(D)PT, definito come il tempo dal giorno 0 alla visita più vicina alla quale viene riscontrato un miglioramento sostanziale dell'indice CAI pari o superiore al 50% (scala CAI Rachmilewitz, 1989)
    E.2.2Secondary objectives of the trial
    To determine: • remission at Weeks 4, 8 and 12, defined as CAI ≤3. • response at Weeks 4, 8 and 12, defined as an improvement in CAI of ≥50% from Day 0. • improvement in CAI during the (total) treatment period defined as the area under the curve of CAI values from Day 1 until Week 8. • response at Week 8, defined as a decrease from baseline in Disease Activity Index (DAI) of 30% or more. • response at Week 8, defined as a change from baseline in endoscopy index (EI) of >1.5. • endoscopic remission, defined as flexible proctosigmoidoscopy score of 0at Week 8. • the improvement in faecal calprotectin concentration from baseline to Weeks 4, 8, and 12. • the improvement in C-reactive protein (CRP) from baseline to Weeks 4, 8, and 12. • the improvement in the score for Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to Weeks 8 and 12. • the incidence of adverse events.
    Determinare: • la remissione alle Settimane 4, 8 e 12, definite come CAI ≤3 . • la risposta alle Settimane 4, 8 e 12, definita come miglioramento CAI ≥50% dal Giorno 0. • un miglioramento CAI durante il trattamento definito come l’area sotto la curva dei valori CAI dal Giorno 1 fino alla Settimana 8. • la risposta alla Settimana 8, definita come riduzione nell’indice di attività della malattia del 30% o più. • la risposta alla Settimana 8, definita come cambiamento nell’Indice endoscopico di &gt;1.5. • la remissione endoscopica, definita come punteggio alla proctosigmoidoscopia flessibile di 0 alla Settimana 8. • il miglioramento nella calprotectina fecale dal basale alle Settimane 4, 8 e 12. • il miglioramento nella PCR dal basale alle Settimane 4, 8 e 12 • il miglioramento nel punteggio dell’IBD dal basale alle Settimane 8 e 12 • l’incidenza di eventi avversi durante lo studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .written informed consent. .males or females, aged 18 to 70 years (inclusive). .Females of childbearing potential must have a negative urine pregnancy test at screening and must agree to use adequate contraception until week 12. .Females of non-child bearing potential should be postmenopausal for >1 year or permanently sterilised. .Male patients must agree to use adequate contraception. .BMI ≥19 and ≤30 kg/m2. .Mild to moderately active UC proven by endoscopy and defined as a CAI of 6 to 12. .Pre-treatment of active ulcerative colitis with a stable dose of oral mesalazine, sulphasalazine or olsalazine for >4 weeks and/or azathioprine or 6-mercaptopurin for >3 months, or oral corticosteroids of ≤20 mg oral prednisolone or equivalent for >2 weeks.
    .Consenso Informato. .Pazienti da 18 a 70 compresi. .Donne in età fertile con test gravidanza neg. allo screening che accettano metodo contraccettivo adeguato fino a 12a settimana. .Donne non fertili in postmenopausa &gt; 1 anno o sterilizzate. .Uomini uso di contraccezione adeguata. .BMI ≥19 e ≤30 Kg/m2. .CU lieve moderata attiva dimostrata con endoscopia e CAI compreso fra 6 e 12. .Pretrattamento CU con: mesalazina, sulfasalazina o olsalazina orale &gt; 4 sett. e/o dose stabile azatioprina o 6-mercaptopurina &gt; 3 mesi o dose stabile di cortocosteroidi orali ≤ 20 mg prednisolone o equivalente &gt; 2 sett.
    E.4Principal exclusion criteria
    1.Pregnant, planning to become pregnant during the study, or breast feeding females. 2.Previous participation in any clinical study with K(D)PT. 3.Crohn’s disease. 4.Treatment-naive. 5.Infectious diarrhoea within 14 days before or during the treatment period. 6.Indeterminate colitis. 7.Significantly impaired liver, renal, pulmonary or cardiovascular function. 8.Use of antibiotics within 4 weeks before or during the treatment period. 9.Use of E. coli Nissle within 4 weeks before or during the treatment period. 10.Previous use of cyclosporine, anti-TNF therapy (e.g. infliximab) or tacrolimus at any time. 11.Any rectal therapy four weeks before or during the treatment period. 12.Use of corticosteroids >20 mg oral prednisolone or equivalent. 13.Use of methotrexate within 3 months before or during the treatment period. 14.Use of anti-diarrhoeal drugs within 2 weeks before or during the treatment period. 15.Effective anti-coagulation therapy (e.g. Marcumar) or severe grade coagulation defects. 16.Any clinically relevant abnormal findings at screening, vital signs or ECG which, in the opinion of the investigator, may put the patient at risk because of his or her participation in the study. 17.History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or could influence the results, or the patient’s ability to participate in the study. 18.History of or current alcohol or drug abuse, as judged by the investigator. 19.Participation in another investigational drug study within 3 months before first administration of study medication. 20.Donation of blood within 3 months, or donation of plasma within 2 weeks, before the first administration of study medication. 21.Proctitis (≤5 cm). 22.QTcF >450 ms or <350 ms or QT >500 ms or other relevant ECG abnormality as judged by the investigator. 23.History of pathological skin condition. 24.Known intolerance to methylparaben or propylparaben. 25.Known intolerance to any other excipient of the investigational medicinal product (IMP). 26.Positive history of hepatitis B and/or C and/or history of human immunodeficiency virus (HIV). 27.Planned surgery or hospitalisation during the study. 28.Patients who, in the opinion of the investigator, should not participate in the study. 29.Patients unable to understand informed consent.
    1.Donne in stato di gravidanza, che stanno pianificando una gravidanza durante lo studio o in allattamento. 2.Precedente partecipazione in qualsiasi studio clinico con K(D)PT. 3.Malattia di Crohn. 4.Senza trattamenti precedenti. 5.Diarrea infettiva nei 14 giorni precedenti o durante il periodo di trattamento. 6.Colite di natura non determinata. 7.Significativa compromissione della funzionalità epatica, renale, polmonare o cardiovascolare. 8.Uso di antibiotici nelle 4 settimane precedenti o durante il periodo di trattamento. 9.Uso di E. coli Nissle nelle 4 settimane precedenti o durante il periodo di trattamento. 10.Uso precedente di ciclosporina, terapia anti-TNF (per esempio infliximab) o tacrolimus in qualsiasi momento. 11.Qualsiasi terapia rettale quattro settimane prima o durante il periodo di trattamento. 12.Uso di corticosteroidi &gt;20 mg prednisolone orale o equivalente. 13.Uso di metotrexato entro 3 mesi prima o durante il periodo di trattamento. 14.Uso di farmaci antidiarroici entro 2 settimane prima o durante il periodo di trattamento. 15.Efficace terapia anticoagulante (per esempio Marcumar) o gravi difetti di coagulazione. 16.Qualsiasi referto anomalo clinicamente rilevante allo screening, segni vitali o ECG che, a giudizio dello sperimentatore, possano esporre il soggetto a rischi a causa della sua partecipazione allo studio. 17.Storia di qualsiasi patologia o disturbo clinicamente significativo che, a giudizio dello sperimentatore, potrebbero esporre il soggetto a rischi a causa della sua partecipazione allo studio o potrebbero influenzare i risultati o la capacità del soggetto a partecipare allo studio. 18.Abuso presente o passato di alcool o droghe, a giudizio dello sperimentatore. 19.Partecipazione a un altro studio su un farmaco sperimentale nei 3 mesi precedenti la prima somministrazione del farmaco di studio. 20.Donazione di sangue nei 3 mesi o donazione di plasma nelle 2 settimane precedenti la prima somministrazione del farmaco di studio. 21.Proctite (≤5 cm). 22.QTcF &gt;450 ms o &lt;350 ms o QT &gt;500 ms o altra anomalia ECG rilevante a giudizio dello sperimentatore. 23.Storia di condizione cutanea patologica. 24.Nota intolleranza a metilparaben o propilparaben. 25.Nota intolleranza a uno qualsiasi degli altri eccipienti del farmaco sperimentale (IMP). 26.Storia positiva di epatite B e/o C e/o storia di virus dell’immunodeficienza umana (HIV). 27.Intervento chirurgico o ricovero pianificati durante lo studio. 28.Pazienti che, a giudizio dello sperimentatore, non dovrebbero partecipare allo studio. 29.Pazienti non in grado di comprendere il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to sustained response to study medication, where response is defined as an improvement in CAI of ≥50% from Day 0 (CAI scored according to Rachmilewitz, 1989).
    L'Endpoint primario è il tempo per ottenere una risposta soddisfacente alla terapia medica dove la risposta è definita come un miglioramento nell'indice CAI pari o superiore al 50% dal giorno 0 (puntegio CAI secondo Rachmilewitz 1989).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Frequency of remission, defined as CAI <-3 (CAI scored according to Rachmilewitz,1989), at Weeks 4, 8 and 12. • Response to study medication at Weeks 4, 8 and 12, where response is defined as an improvement in CAI of >-50% (CAI scored according to Rachmilewitz, 1989). • Area under the curve for the change from baseline in CAI scores during the (total) treatment period from Day 1 until Week 8 (CAI scored according to Rachmilewitz, 1989). • Frequency of response rates at Week 8 with response defined as decrease from baseline in DAI of 30% or more (DAI scored according to Mayo Score, as defined in Schroeder et al., 19877). • Frequency of response rates at Week 8 with response defined as change from baseline in EI of >1.5 (according to Mayo Score, as defined in Schroeder et al., 19877; flexible proctosigmoidoscopy assessment). • Frequency of patients with endoscopic remission (patients with a flexible proctosigmoidoscopy score of 0 at Week 8). • Change from baseline to Weeks 4, 8, and 12 in faecal calprotectin concentrations. • Change from baseline to Weeks 4, 8, and 12 in CRP concentrations. • Change from baseline to Week 8 and 12 in IBDQ scores.
    .Frequenza di remissione definita come CAI pari o inf. a 3 alla settimana 4, 8 e 12. .Risposta alla terapia in studio alla settimana 4, 8 e 12 (miglioramento del CAI pari o sup. al 50%. .Area sotto la Curva della variazione nel punteggio CAI dal giorno 1 fino alla settimana 8. .Percentuale di risposta alla 8a settimana dove la risposta viene definita come riduzione dal basale nell’indice di attività della malattia (DAI) del 30% o superiore. .Percentuale di risposta alla 8a settimana dove la risposta viene definita come cambiamento dal basale nell’Indice endoscopico (EI) di >1.5. .Frequenza di pazienti con remissione endoscopica (punteggio 0 alla 8a settimana). .Variazione della concentrazione fecale di calprotectina dal baseline alla settimana 4, 8 e 12. .Variazione della concentrazione di PCR dal baseline alla settimana 4, 8 e 12. .Variazione della IBDQ dal baseline alla settimana 4, 8 e 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 months18
    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 months18
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 160
    F.4.2.2In the whole clinical trial 160
    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)
    4 weeks after completion of the treatment period, patients will be seen for the following assessment:
    . Record any AEs;
    . any changes in concomitant medications;
    Stool diary collected;
    . Vital Signs;
    . CAI;
    . Stoolo samples for analysis of bacteria and faecal clprotectin level;
    . routine hematology;
    . ECG and IBDQ
    4 settimane dopo la fine del trattamento, i pazienti saranno visitati dal medico sperimentatore per valutare e registrare:
    . la presenza di eventuali EA;
    . qualsiasi modifica nei trattamenti concomitanti;
    . il diario della raccolta delle feci;
    . i segni vitali (PA, FC, TC e peso);
    . l'indice CAI;
    . i campioni di feci per l'analisi di batteri patogeni e i livelli di calprotectina fecale;
    . campione di sangue per la routine ematologica;
    . ECG e IBDQ.
    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 Decision2012-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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