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    Summary
    EudraCT Number:2011-001935-21
    Sponsor's Protocol Code Number:8-55-52133-010
    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 number2011-001935-21
    A.3Full title of the trial
    An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide and related items in blood samples from subjects who previously received taspoglutide and experienced a systemic allergic reactuin
    Uno studio interventistico non terapeutico destinato a valutare l`™attivazione ex vivo dei basofili in risposta alle preparazioni di taspoglutide ed elementi correlati in campioni di sangue prelevati da soggetti che hanno ricevuto in precedenza taspoglutide e sperimentato una reazione allergica sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide
    Uno studio interventistico non terapeutico destinato a valutare l’attivazione ex vivo dei basofili in risposta alle preparazioni di taspoglutide
    A.4.1Sponsor's protocol code number8-55-52133-010
    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 SponsorIPSEN PHARMA SAS
    B.1.3.4CountryFrance
    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 supportIpsen Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma SAS
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address65 Quai George Gorse
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33160929480
    B.5.5Fax number+33160929462
    B.5.6E-mailct-application@ipsen.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 nameTaspoglutide
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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
    Diabetes
    Diabete
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabete
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the occurrence of positive reaction (basophil activation signal)
    to various taspoglutide formulations (including taspoglutide used in
    Phase III clinical trials, extra-pure (EP) taspoglutide, taspoglutide used
    in Phase II (active pharmaceutical ingredient (API) from Polypeptide
    Laboratories, Inc.), synthetic impurities of taspoglutide, placebo and
    another GLP-1 analogue (liraglutide) in blood samples of subjects who
    received taspoglutide in the T-Emerge Programme studies and
    experienced a systemic allergic reaction
    Valutare l'insorgenza di una reazione positiva (segnale di attivazione dei basofili) in formulazioni varie di taspoglutide (tra cui il taspoglutide utilizzato negli studi clinici di fase III, il taspoglutide extrapuro (EP), il taspoglutide impiegato negli studi clinici di fase II (principio attivo farmaceutico (API) di Polypeptide Laboratories, Inc.), le impurità sintetiche del taspoglutide, il placebo e un altro analogo del GLP-1 (liraglutide) in campioni di sangue prelevati da soggetti che hanno ricevuto taspoglutide nel corso di uno degli studi del Programma T-Emerge e che hanno riscontrato una reazione allergica sistemica.
    E.2.2Secondary objectives of the trial
    None
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects who, during one of the Roche T-Emerge Programme studies,
    experienced a serious or non-serious adverse event (AE) that is
    suggestive of a possible systemic allergic reaction to the study drug (per
    the Investigator's assessment).
    - Ability and willingness to give written informed consent and to provide
    a blood sample for the BAT.
    • Soggetti che, nel corso di uno studio del Programma T-Emerge di Roche, hanno sperimentato un evento avverso (EA) grave o non grave, indicativo di una possibile reazione allergica sistemica al farmaco in studio (secondo la valutazione dello Sperimentatore);
    • Capacità e volontà di fornire il proprio consenso informato scritto e di sottoporsi al prelievo di un campione di sangue per il BAT.
    E.4Principal exclusion criteria
    • Subjects who participated in any other clinical study within 30 days
    prior to screening or who may enter another clinical study during the
    course of this study.
    • Subjects who experienced a systemic allergic reaction, during one of
    the Roche T-Emerge Programme Studies, more than 24 months prior to
    screening.
    • Subjects who received immunosuppressants within 1 week prior to
    screening.
    • Subjects who received any GLP-1 mimetic/analogue other than
    taspoglutide at any time.
    • Subjects who received taspoglutide since the last administration in
    the T-Emerge Programme.
    • Soggetti che hanno partecipato a qualsiasi altro studio clinico nei 30 giorni precedenti allo screening o che potrebbero essere arruolati in un altro studio clinico nel corso del presente studio;
    • Soggetti che hanno manifestato una reazione allergica sistemica nel corso di uno studio del Programma T-Emerge di Roche più di 24 mesi prima dello screening;
    • Soggetti che hanno ricevuto farmaci immunosoppressori nel corso della settimana precedente allo screening;
    • Soggetti che, in qualsiasi momento, hanno ricevuto qualsiasi analogo/mimetico del GLP-1 diverso dal taspoglutide;
    • Soggetti che hanno ricevuto taspoglutide dopo l'ultima somministrazione nell’ambito del Programma T-Emerge.
    E.5 End points
    E.5.1Primary end point(s)
    Positive or negative reaction in BAT (Basophil Activation Test)
    Reazione positiva o negativa durante il BAT, come descritta nel documento di istruzioni sul BAT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The BAT is to be perfomed within 56 hours of Blood draw
    Il BAT deve essere eseguito entro 56 ore dal prelievo di sangue
    E.5.2Secondary end point(s)
    None
    Nessuno
    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 No
    E.6.5Efficacy No
    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
    assess the positive reaction in ex vivo BAT in pt. with AEs suggestive of a systemic allergic reac.
    valutare la reazione positiva in ex-vivo BAT in pz. che hanno sper. EA indicativi di Reaz.All.Sist.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Brazil
    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 trial ends when the last patient would have completed Visit 1 when the blood samples are collected. This visit is the only visit planned in the study.
    Lo studio finisce quando l'ultimo paziente avrà completato Visita 1 e il campione di sangue sarà stato raccolto. La visita è l'unica pianificata nello studio.
    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 months8
    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 months8
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 29
    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)
    No study treatment is given to the patient in the study. Patients will receive their usual treatment prescribed from their own physicians
    nessun trattamento è dato ai pazienti nello studio. I pazienti riceveranno il loro usuale trattamento prescritto dal loro medico.
    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 Decision2011-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-21
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