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    Summary
    EudraCT Number:2017-001405-32
    Sponsor's Protocol Code Number:IMIS2017-02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-19
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001405-32
    A.3Full title of the trial
    A Monocentric Single-arm study to characterize the long-term safety, efficacy, and pharmacodynamic of GLP-2 analog (Revestive®) in the management of short bowel syndrome pediatric patients on home-parenteral nutrition (HPN)
    Essai monocentrique, simple bras, pour la caractérisation de la tolérance à long terme, de l’efficacité et de la pharmacodynamie de l’analogue au GLP-2 (Révestive®) dans la prise en charge des patients ayant un syndrome du grêle court sous nutrition parentérale à domicile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monocentric Single-arm study to characterize the long-term safety, efficacy, and pharmacodynamic of GLP-2 analog in the management of short bowel syndrome pediatric patients on home-parenteral nutrition
    A.3.2Name or abbreviated title of the trial where available
    REVE
    A.4.1Sponsor's protocol code numberIMIS2017-02
    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 SponsorInstitut des Maladies Génétiques - Imagine
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstitut des maladies Génétiques - Imagine
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut des maladies Génétiques - Imagine
    B.5.2Functional name of contact pointElisabeth Hulier-Ammar
    B.5.3 Address:
    B.5.3.1Street Address24 boulevard du Montparnasse
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75015
    B.5.3.4CountryFrance
    B.5.5Fax number33142754362
    B.5.6E-mailelisabeth.hulier-ammar@institutimagine.org
    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 Yes
    D.2.1.1.1Trade name Revestive
    D.2.1.1.2Name of the Marketing Authorisation holderShire pharmaceutical
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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/3/01/077
    D.3 Description of the IMP
    D.3.1Product nameteduglutide
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Short Bowel Syndrom
    E.1.1.1Medical condition in easily understood language
    Short Bowel Syndrom
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of Revestive® to decrease PN using PN/REE ratio in pediatric patients (aged 1 year through 18 years) with short bowel syndrome (SBS) who are dependent on parenteral support.
    E.2.2Secondary objectives of the trial
    - To evaluate the impact of Revestive® on ostomy flow
    - To quantify the impact of Revestive® on the number of perfusions in a week
    - To evaluate the impact of Revestive® on diarrhea
    - To evaluate the impact of Revestive® on intestinal absorption using stool balance
    - To evaluate the long term safety of Revestive®
    - To evaluate the response rate to Revestive®


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Being aged from 2 to 18 years old included ;
    - Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or left with less than 120 cm in case of SBS caused by Hirschsprung disease;
    - Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ;
    - Being dependent on PN for at least 2 year and enterally fed (oral or tube feeding) ;
    - Having a normal colonoscopy in the 12 month before screening (for children with a SBS type 2 or 3 older than 12 years) ;
    E.4Principal exclusion criteria
    - Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
    - Having a clinically significant untreated intestinal obstruction or active stenosis ;
    - Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
    - Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
    - Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
    - Having an history of cancer or clinically significant lymphoproliferative disease; excepted resected cutaneous basal or squamous cell carcinoma, or in situ non-aggressive and surgically resected cancer ;
    - Having participated in a clinical study using an experimental drug within 1 month or an experimental antibody treatment within 3 months prior to screening, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide ;
    - Having already used native GLP-2 and glucagon-like peptide-1 analog or human growth hormone within 3 months prior to screening ;
    - Having already used oral or IV glutamine, octreotide, or dipeptidyl peptidase IV (DPP-IV) inhibitors within 3 months prior to screening ;
    - Having an active Crohn’s disease which has been treated with biological therapy within the 6 months prior to screening ;
    - Having an intestinal polyposis;
    - Being, for female patient, both lactating and breast-feeding or having a positive pregnancy test during the screening period;
    - Refusing the follow the protocol requirements in terms of birth control ;
    - Being unable to follow the study procedures for any reason: psychological, geographical…
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of patients who achieve a ≥ 20% reduction of PN/REE from baseline to week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    E.5.2Secondary end point(s)
    To evaluate the impact of Revestive® on ostomy flow
    Ostomy flow will be assessed only for patient with a SBS type 1 by evaluations of:
    - Ostomy output/stool balance testing
    - Urine output (only during hospitalizations) from baseline to EOT
    - Changes in plasma citrulline

    To quantify the impact of Revestive® on the number of perfusions in a week
    - Change in days per week of PN as well as any patients who are able to completely wean off PN support
    - Increase in enteral nutritional tolerance (calories and volume)
    - Decrease in parenteral support (calories and volume)

    To evaluate the impact of Revestive® on diarrhea
    Diarrhea will be assessed only for patient with a SBS type 2 or 3 by evaluation of:
    - Changes in number of stools per day
    - Changes in stools consistency

    To evaluate the impact of Revestive® of intestinal absorption using stool balance
    Stool balance will be assessed by evaluations of:
    - Ingesta (calorimetric measure)
    - Stool weight/24h (reported to the patient’s weight)
    - Percentage of lipid absorption
    - Percentage of nitrogen absorption
    - Percentage of carbohydrate absorption
    - Percentage of total caloric absorption
    - Sodium in stool

    To evaluate the long term Safety of Revestive®
    Safety and tolerability will be assessed by evaluations of:
    - Adverse events, including GI symptoms
    - Physical examinations
    - Vital signs, including body weight, heart rate, and blood pressure
    - Electrocardiograms
    - Laboratory safety data, including electrolyte balance and glucose
    - Maintaining the growth; including weight, brachial perimeter, and length
    - Oral/enteral feeding tolerance
    - Nutritional intake and urinary/fecal output (intake/output)
    - Results of routine clinical evaluations including physical examination, and where appropriate, GI-specific testing including imaging (colonoscopy) abdominal ultrasound, fecal occult blood testing)

    To evaluate the response rate to Revestive®
    The response rate to Revestive® and the identification of good responders will be done by assessment of:
    - The endogenous GLP-2 rates
    - The comparison of the patients’ SBS type
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 Yes
    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 visit of the last patient (LVLP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Minor patients (consent will be obtained from parents or legal representative)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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)
    Follow-up of patients in the frame of their routine and usual care
    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 Decision2017-09-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-13
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