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    Summary
    EudraCT Number:2012-001340-21
    Sponsor's Protocol Code Number:KB046
    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:2012-10-09
    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 number2012-001340-21
    A.3Full title of the trial
    A Historically-Controlled Phase II/III study to Evaluate Efficacy and Safety of Kedrion Human Plasminogen Eye Drop Preparation in Patients Diagnosed with Ligneous Conjunctivitis
    Studio di Fase II/III, storicamente controllato, per la valutazione dell'efficacia e sicurezza del collirio Kedrion a base di Plasminogeno umano in pazienti affetti da Congiuntivite Lignea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study aimed to Evaluate Efficacy and Safety of Kedrion Human Plasminogen Eye Drop Preparation in Patients Diagnosed with Ligneous Conjunctivitis
    Studio clinico per la valutazione dell’efficacia e sicurezza del collirio Kedrion a base di Plasminogeno umano in pazienti affetti da Congiuntivite Lignea.
    A.4.1Sponsor's protocol code numberKB046
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01554956
    A.5.4Other Identifiers
    Name:14953Number:IND 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 SponsorKEDRION
    B.1.3.4CountryItaly
    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 supportKedrion SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKedrion SpA
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressBarga (Lucca)
    B.5.3.2Town/ cityAi Conti - Castelvecchio Pascoli
    B.5.3.3Post code55051
    B.5.3.4CountryItaly
    B.5.4Telephone number05831969231
    B.5.5Fax number05831969600
    B.5.6E-maila.lotti@kedrion.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/461
    D.3 Description of the IMP
    D.3.1Product nameKedrion Human Plasminogen
    D.3.2Product code NA
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHuman Kedrion Plasminogen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    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 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
    Ligneous Conjunctivitis ( MedDRA Code vers. 15.0: 10071570 LLT - no present in OsSC database) associated with Type I Plasminogen Deficiency
    Congiuntivite Lignea (Codice MedDRA vers. 15.0: 10071570 LLT - non presente nel database OsSC)da Deficit di Plasminogeno di Tipo I
    E.1.1.1Medical condition in easily understood language
    Ligneous Conjunctivitis
    Congiuntivite Lignea
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.Evaluation of the efficacy of the IMP, Kedrion Human Plasminogen eye drop preparation, for the treatment of Ligneous Conjunctivitis associated with Type I plasminogen deficiency in symptomatic subjects 2.Evaluation of the safety of the IMP in symptomatic subjects and asymptomatic subjects with a history of ocular pseudomembranes
    1.Valutazione dell’efficacia del collirio Kedrion a base di Plasminogeno Umano per il trattamento della Congiuntivite Lignea associata a Deficit di Plasminogeno di Tipo I 2.Valutazione della sicurezza dell’IMP in soggetti sintomatici e asintomatici con una storia di pseudomembrane oculari
    E.2.2Secondary objectives of the trial
    1.Evaluation of the efficacy of the IMP in the regression of pseudomembranes in symptomatic subjects 2.Assessment of the local tolerability of the IMP 3.Assessment of the immunogenicity of the IMP
    1.Valutazione dell’efficacia dell’IMP nella regressione di pseudomembrane in pazienti sintomatici 2.Valutazione della tollerabilità locale in seguito a somministrazione dell’IMP 3.Valutazione dell’immunogenicità associata all’IMP
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    'Plasminogen Molecular analysis', inserted in Appendix 1 of the study protocol, aimed to detect the existence of genetic variations related to the gene of Plasminogen.

    ALTRI SOTTOSTUDI:
    'Plasminogen Molecular analysis' inserito in appendice 1 del protocollo di studio, finalizzato a rilevare l’esistenza di variazioni genetiche correlate al gene del Plasminogeno.

    E.3Principal inclusion criteria
    1.Subjects should be diagnosed with Ligneous Conjunctivitis associated with Type I plasminogen deficiency, confirmed by the central laboratory and documented at pre-enrollment screening. The concomitant presence of other ligneous pseudomembranes at different sites will not constitute an exclusion criterion. 2.Subjects should have documented historical record or knowledge of lifetime disease course, including age of LC onset, history of pseudomembrane lesions, disease duration, past treatment for Ligneous Conjunctivitis, response to treatment (including regression and recurrence) available for at least 6 months before study entrance. 3.Subjects, or their legally authorized representative, in the case of study participants < 18 years of age, should have been informed of the nature of the study, agreed to its provision, signed and dated the informed consent approved by the IRB or EC. 4.Subjects available for the duration of the study will be included. The Investigator will make sure that there is no plan for the subject to leave the area of the study site before the end of the study period. If they come from another center, they must agree to be compliant and come back for follow-up.
    1. Pazienti con diagnosi di Congiuntivite Lignea associata a Deficit di Plasminogeno di Tipo I, confermato dal laboratorio centrale e documentato alla visita di screening. La presenza concomitante di pseudomembrane lignee in altri apparati non costituirà un criterio di esclusione. 2.Pazienti che possono documentare la storia clinica della propria patologia o che comunque sono a conoscenza delle caratteristiche del decorso della propria malattia (età di insorgenza, storia delle pseudomembrane, durata, trattamenti passati ed eventuali risposte incluse la regressione o la ricomparsa di pseudomembrane), per almeno 6 mesi precedenti al suo ingresso nello studio. 3.Pazienti o i loro rappresentanti legali (in caso di età &lt;18 anni) che sono stati informati sulla natura dello studio, sono d’accordo ed hanno firmato e datato il modulo di consenso informato approvato dall’Investigational Review Bord o dal Comitato Etico. 4.Pazienti disponibili per tutta la durata dello studio. Lo sperimentatore si assicurerà che i soggetti non abbiano pianificato di allontanarsi dall’area in cui si svolge la sperimentazione prima della fine del periodo di ricerca. Nel caso in cui provengano da un altro centro, dovranno acconsentire a presentarsi al centro per tutte le visite di Follow Up.
    E.4Principal exclusion criteria
    1.Subjects presenting LC not associated with Type 1 plasminogen deficiency. 2.Subjects with no history of LC lesions. 3.Subject presenting antibodies against aprotinin or plasminogen at screening. 4.Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial. 5.Subjects unwilling to give written informed consent or assent to participation. 6.Subjects who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study. 7.Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device [IUD], abstinence or other prescribed birth control). 8.Females who are breastfeeding.
    1.Pazienti che presentano Congiuntivite Lignea non associata a Deficit di Plasminogeno di Tipo 1. 2.Pazienti che senza una storia di lesioni correlate alla Congiuntivite Lignea 3.Pazienti che presentano anticorpi contro l’aprotinina o il plasminogeno allo screening 4.Pazienti con patologie concomitanti che, ad opinione dello Sperimentatore, potrebbero interferire con la valutazione degli obiettivi previsti da protocollo o con la partecipazione del soggetto a questo studio. 5.Pazienti che non hanno firmato il Modulo di Consenso informato o Assenso alla partecipazione. 6.Pazienti che hanno partecipato ad un altro studio clinico entro un mese dall’inizio dello studio, i.e. soggetti che hanno ricevuto un farmaco sperimentale nei 30 giorni precedenti. 7.Donne in età fertile che sono in gravidanza o non usano un adeguato metodo di controllo delle nascite (per adeguato si intende contraccettivi ormonali, vasectomia del partner da almeno 3 mesi, preservativo, spirale, astinenza o altri metodi di controllo delle nascite prescritti). 8.Donne in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY The prevention of pseudomembrane recurrence during Segment 2 after: •Surgical removal of pseudomembranes, in cases where there is no pseudomembrane regression or partial regression following initial treatment with the IMP (Group 1B); or •Complete pseudomembrane regression during Segment 1 in response to treatment with the IMP (Group 1A). SAFETY Clinical safety will be assessed in all subjects receiving any dose of IMP by evaluating: •Vital signs (blood pressure, heart rate, temperature and respiratory rate. •Adverse Events throughout the study. •Immunogenicity. Blood samples will be taken before starting the treatment at study entry, at the 4-week evaluation, and every 4 weeks thereafter to measure antibodies against human plasminogen and antibodies against bovine aprotinin. •Viral Safety. A pre-treatment serum sample from each subject included in the clinical trial will be stored at a temperature below -70°C for possible future viral testing. A post-treatment serum sample, from each subject who received the IMP at least once, will be collected at the termination visit for comparison. •Local tolerability. Signs and symptoms of sensitization will be collected throughout the study.
    EFFICACIA Prevenzione della ricomparsa delle Pseudomembrane durante il Segmento 2 dopo: •Rimozione chirurgica delle Pseudomembrane nei pazienti che non presentano parziale o totale regressione delle stesse dopo l’iniziale somministrazione dell’IMP (Gruppo 1B); o •Regressione completa delle Pseudomembrane durante il Segmento 1 in risposta al trattamento con l’IMP (Gruppo 1A). SICUREZZA La sicurezza clinica sarà determinata in tutti i pazienti che riceveranno l’IMP tramite la valutazione di: •Segni Vitali (pressione sanguigna, frequenza cardiaca, temperatura e frequenza respiratoria). •Eventi avversi riportati durante lo studio. •Immunogenicità. Campioni di sangue saranno prelevati prima dell’inizio del trattamento, alla quarta settimana e, successivamente, ogni 4 settimane al fine di rilevare la presenza di anticorpi contro il plasminogeno umano e l’aprotinina bovina. •Sicurezza virale. Prima del trattamento, sarà prelevato un campione di siero da ogni paziente incluso nello studio clinico che verrà conservato a temperatura < –70 °C per possibili esami virali futuri. Un secondo prelievo sarà eseguito al termine della ricerca in tutti i pazienti che hanno ricevuto l’IMP almeno una volta e sarà confrontato con quello prelevato prima del trattamento. •Tollerabilità locale. Saranno registrati tutti i segni e sintomi di sensibilizzazione durante l’intera durata dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    EFFICACY 12-34 weeks SAFETY All study period, including the continuation segment up to the product licensing or 12 months from the last patient exit
    EFFICACIA 12-34 settimane SICUREZZA Per tutto il periodo di studio, incluso il periodo di mantenimento fino alla commercializzazione del prodotto o comunque non otre i 12 mesi dall'uscita dell'ultimo paziente dallo studio.
    E.5.2Secondary end point(s)
    •Regression of surface areas of existing ligneous pseudomembranes (using objective measurement) at the end of Study Segment 1; •Time to ligneous pseudomembrane re-appearance after surgery or complete regression (days) during Study Segment 2.
    •Diminuzione delle dimensioni delle Pseudomembrane pre-esistenti (usando misurazioni oggettive) alla fine del Segmento 1; •Tempo di ricomparsa di nuove Pseudomembrane dopo la rimozione chirurgica di quelle pre-esistenti o completa regressione delle stesse (in giorni) durante il Segmento 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-34 weeks
    12-34 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over 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 Yes
    E.8.2.3.1Comparator description
    Controllo Storico
    Historically-Controlled
    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 concerned3
    E.8.5The trial involves multiple Member States No
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 10
    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)
    ND
    ND
    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 Decision2013-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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