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    Summary
    EudraCT Number:2013-002244-86
    Sponsor's Protocol Code Number:REP0113
    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:2013-06-13
    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 number2013-002244-86
    A.3Full title of the trial
    Effect of reparixin on long-term outcomes after pancreatic islet
    transplantation in type 1 diabetes mellitus patients. A non-interventional, monocentre study to extend up to 3 years the follow-up of patients treated with reparixin under protocol REP0110.
    Efficacia a lungo termine di Reparixin dopo un trapianto di isole pancreatiche in pazienti con diabete mellito di tipo 1. Studio non interventistico monocentrico per estendere a 3 anni il follow-up dei pazienti trattati con Reparixin nello studio REP0110
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    extention up to 3 years of the follow-up of patients treated with reparixin under protocol REP0110.
    estensione a 3 anni del follow-up dei pazienti trattati con Reparixin nello studio REP0110
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberREP0113
    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 SponsorDompé s.p.a.
    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 supportDompé s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé s.p.a.
    B.5.2Functional name of contact pointDevelopment Project Manager
    B.5.3 Address:
    B.5.3.1Street Addressvia Santa Lucia, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number00390258383500
    B.5.5Fax number00390258383324
    B.5.6E-mailinfo@dompe.it
    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/3/01/058
    D.3 Description of the IMP
    D.3.1Product nameReparixin
    D.3.2Product code DF 1681Y
    D.3.4Pharmaceutical form Concentrate 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 INNReparixin
    D.3.9.1CAS number 266359-83-5
    D.3.9.2Current sponsor codeDF 1681Y
    D.3.9.3Other descriptive nameREPARIXIN
    D.3.9.4EV Substance CodeSUB31277
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number330
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients who have received pancreatic islet transplantation
    pazienti che hanno ricevuto trapianto di isole pancreatiche
    E.1.1.1Medical condition in easily understood language
    patients who have received pancreatic islet transplantation
    pazienti che hanno ricevuto trapianto di isole pancreatiche
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    The objective of this extension study is to evaluate whether treatment with reparixin at the time of islet transplantation improves long-term outcome of pancreatic islets allotransplantation
    l’obiettivo di questo studio clinico è valutare l’efficacia a lungo termine di reparixin nei pazienti con diabete mellito di tipo 1 che hanno ricevuto il farmaco sperimentale durante il loro trapianto di isole pancreatiche
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients enrolled and treated with reparixin in the REP0110 study.
    2. Patients with a functioning graft at last follow-up visit (stimulated serum C-peptide levels > 0.3 ng/mL derived from the MMTT).
    3. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
    4. Patients who have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
    - pazienti sottoposti a trapianto intra-epatico di isole pancreatiche e trattati con reparixin nello studio REP0110.
    - pazienti che avevano trapianto funzionante al momento dell’ultima visita di follow-up dello studio REP0110 (livelli di C-peptide sierico prelevati durante il test di tolleranza dopo pasto misto (MMTT) > 0.3 ng/m).
    - pazienti consenzienti e in grado di soddisfare tutte le procedure dello studio, inclusa la presenza a tutte le visite programmate.
    - pazienti che hanno dato il consenso informato scritto prima di essere sottoposti a qualsiasi procedura dello studio, e consci del fatto che è possibile ritirare il proprio consenso in ogni momento senza subire conseguenze per la loro assistenza sanitaria futura.
    E.4Principal exclusion criteria
    not applicable
    non applicabile
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints will be:
    The proportion of insulin-independent patients following islet cell transplantation
    [time frame: month 24, 36 after the last transplant].
    Total time of insulin independence after the transplant [time frame: up to 3 years after the last transplant].
    Change in average daily insulin requirements (absolute and % decrease from pretransplant levels) [time frame: month 24, 36 after the last transplant].
    Glycated hemoglobin (HbA1c) (absolute and % decrease from pre-transplant levels) [time frame: month 24, 36 after the last transplant].
    The proportion of patients free of severe hypoglycaemic events [time frame: month 24, 36 after the last transplant].
    Basal (2 basal samples in the range between -20 to 0) to 120 min time course of glucose, C-peptide and insulin derived from the mixed meal tolerance test (MMTT) [time frame: month 24, 36 after the last transplant].
    β-cell function as assessed by β-score and Transplant Estimated Function (TEF) [time frame: month 24, 36 after the last transplant].
    Safety endpoints will be:
    Incidence of serious adverse events (SAEs) [time frame: up to 3 years after the last transplant].
    Exploratory endpoints:
    Auto-antibodies (GAD, IA-2, IAA, ZnT8) [time frame: month 24, 36 after the last transplant].
    Anti-HLA antibodies (optional) [time frame: month 24, 36 after the last transplant].
    End point primario:
    - Proporzione di pazienti con insulino-indipendenza dopo trapianto di isole pancreatiche [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Tempo totale di insulino-indipendenza [tempistica: fino a tre anni dopo l’ultimo trapianto].
    - Variazione del fabbisogno medio giornaliero di insulina (valori assoluti e percentuale di riduzione rispetto ai valori pre-trapianto) [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Livelli di emoglobina glicata (HbA1c) (valori assoluti e percentuale di riduzione rispetto ai valori pre-trapianto) [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Proporzione di pazienti senza episodi di ipoglicemia severa [tempistica: mese 1, 3, 6, 12 dopo il trapianto].
    - Proporzione di pazienti senza episodi di ipoglicemia con ridotta percezione [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Livelli di glucosio, C-peptide e insulina al basale (2 campioni raccolti nell’intervallo da 30 a 0 minuti prima del pasto) e curva tempo-risposta dal basale a 120 minuti derivata dal Mixed Meal Tolerance Test [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Funzione delle β-cellule misurata attraverso il β-score e il Transplant Estimated Function [tempistica: mese 24, 36 dopo l’ultimo trapianto].

    Variabili di tollerabilità:
    - Registrazione degli eventi avversi gravi [tempistica: fino a tre anni dopo l’ultimo trapianto].
    Variabili esplorative:
    - Auto-anticorpi (GAD, IA-2, IAA, ZnT8) [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    - Anticorpi anti-HLA (variabile facoltativa) [tempistica: mese 24, 36 dopo l’ultimo trapianto].
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    E.5.2Secondary end point(s)
    not applicable
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    non interventistico
    non interventional
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 years1
    E.8.9.1In the Member State concerned months7
    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 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 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: 3
    F.1.3Elderly (>=65 years) No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3
    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 Decision2013-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-23
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