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    Summary
    EudraCT Number:2011-006201-10
    Sponsor's Protocol Code Number:REP0211
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-006201-10
    A.3Full title of the trial
    A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reparixin in pancreatic islet transplantation
    A.4.1Sponsor's protocol code numberREP0211
    A.5.4Other Identifiers
    Name:INDNumber:15194
    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 organisationWorldwide Clinical Trials Limited
    B.5.2Functional name of contact pointMargui Chia
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, 172 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442071216179
    B.5.5Fax number+442071216160
    B.5.6E-mailmargui.chia@wwctrials.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/3/11/912
    D.3 Description of the IMP
    D.3.1Product nameReparixin
    D.3.2Product code DF1681Y
    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 codeDF1681Y
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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 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
    Pancreatic islet transplantation
    E.1.1.1Medical condition in easily understood language
    Pancreatic islet transplantation
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10058846
    E.1.2Term Pancreas islet cell transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in type 1diabetes (T1D) patients. The safety of reparixin in the specific clinical setting will be also evaluated.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ages 18-70 years, inclusive.
    2. Patients eligible for a pancreatic islet transplantation program based on local accepted practice
    and guidelines. This includes at least:
    - clinical history compatible with T1D with insulin-dependence for >5 years;
    - undetectable (<0.3 ng/mL) stimulated (arginine or MMTT) C-peptide levels.
    Sites will comply with any additional or more stringent criteria locally accepted, as per centre practice.
    3. Planned intrahepatic islet transplantation alone from a non-living donor with brain death.
    4. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
    5. 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.
    E.4Principal exclusion criteria
    1. Recipients of any previous transplant, including recipients of previous pancreatic islet transplantation.
    2. Recipients of islet from a non-heart beating donor.
    3. Pre-transplant average daily insulin requirement >1 IU/kg/day.
    4. Pre-transplant (the more recent value obtained within the 4 months prior to enrolment) HbA1c >11%.
    5. Patients with inadequate renal reserve as per calculated creatinine clearance (CLcr) < 60 mL/min according to the Cockcroft-Gault formula (1976). Should the Investigator suspect this formula is biasing CLcr estimate, another more accurate GFR measurement (e.g MAG3 or DTPA radioisotope scan, 24 hrs inuline clearance, etc.) may be used.
    6. Patients with hepatic dysfunction as defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3mg/dL [>51.3 μmol/L]).
    Patients with Gilbert’s syndrome (elevated unconjugated bilirubin levels in the absence of any evidence of hepatic or biliary tract disease) are not excluded.
    7. Patients who receive treatment for a medical condition requiring chronic use of systemic steroids, except for the use of <5mg prednisone daily or equivalent dose of hydrocortisone, for physiological replacement only.
    8. Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant, apart from the GLP-1 agonists (e.g. exenatide or liraglutide) which will be discontined at least 2 weeks prior to transplant.
    9. Use of any investigational agent within 12 weeks of enrolment, including “anti-inflammatory” strategies (e.g. anti-TNFα, anti-IL-1 RA).
    10. Hypersensitivity to:
    a) ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID).
    b) more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does not qualify for exclusion
    11. Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males). (NB: pregnancy should be avoided in patients or partners during the first month after each treatment with the Investigational Product; no other specific warnings are described, considering even stricter general recommendations concerning pregnancy in transplanted patients, the treatment course of the Investigational Product, its PK profile, and the lack of significant adverse effects on mating performance and fertility in animal studies).
    E.5 End points
    E.5.1Primary end point(s)
    Area Under the Curve (AUC) for the serum C-peptide level during the first 2 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 75+/-5 after the 1st islet infusion and day 365+/-14 after the last islet infusion
    E.5.2Secondary end point(s)
    • The proportion of insulin-independent patients
    • The proportion of patients who achieve and maintain an HbA1c <7.0% (or o reduction in HbA1c >
    2%) AND are free of severe hypoglycaemic events
    • The proportion of patients receiving a 2nd islet infusion
    • Cumulative number of severe hypoglycaemic events
    • Change in average daily insulin requirements (absolute and % decrease from pre-transplant levels)
    • HbA1c % (absolute and % decrease from pre-transplant levels)
    • Basal (fasting) and 0 to 120 min time course of glucose, C-peptide and insulin derived from the
    MMTT
    • β-cell function as assessed by β-score and Transplant Estimated Function (TEF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion].
    [day 365+/-14 after the last islet infusion].
    [day 365+/-14 after the 1st islet infusion].
    [day 365+/-14 after the last islet infusion].
    [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion].
    [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion].
    [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion].
    [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion].
    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 Yes
    E.6.13.1Other scope of the trial description
    Evaluation of the mechanism of action
    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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    France
    Italy
    Sweden
    Australia
    Czech Republic
    United Kingdom
    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
    Last Patient Last Visit (LPLV)
    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 months6
    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 months6
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 42
    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)
    N/A
    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 Decision2012-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-14
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