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    Summary
    EudraCT Number:2018-003575-34
    Sponsor's Protocol Code Number:301084
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-003575-34
    A.3Full title of the trial
    Treatment of bile acid malabsorption with liraglutid
    Behandling af galdesyremalabsorption med liraglutid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of bile acid malabsorption with liraglutid
    Behandling af galdesyremalabsorption med liraglutid
    A.4.1Sponsor's protocol code number301084
    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 SponsorProfessor, Ph.d. MD. Filip Krag Knop
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGentofte Hospital, University of Copenhagen
    B.5.2Functional name of contact pointStene Diabetes Center Copenhagen,
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-mailfilip.krag.knop.01@regionh.dk
    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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Cholestagel
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms.
    Galdesyremalabsorption er en sygdom, hvos der er mere galdesyre i tarmsystemet end hos raske individer. Dette giver vandige diarrere og abdominale gener
    E.1.1.1Medical condition in easily understood language
    Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms.
    Galdesyremalabsorption er en sygdom, hvos der er mere galdesyre i tarmsystemet end hos raske individer. Dette giver vandige diarrere og abdominale gener
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080051
    E.1.2Term Bile acid diarrhoea
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to examine the influence of liraglutide on individuals suffering from bile acid malabsorption (BAM), in a randomised double-blinded, double dummy parallel Group non-inferiority study.
    Studiets formål er at undersøge liraglutids virkning på individer der lider af galdesyremalabsorption i et randomiseret, dobbelt blinded, double dummy, non-inferiør med parallelle grupper studie.
    E.2.2Secondary objectives of the trial
    Not applicable
    ikke anvendelig
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Caucasian ethnicity
    • SeHCAT-verified moderate (5–10% bile acid retention after 7 days) or severe type 2 BAM (<5% retention)
    • Normal haemoglobin (for men 8.3-10.5 mmol/L; for women 7.3-9.5 mmol/L)
    • Age above 18 years and below 75 years
    • Informed and written consent
    • BMI >18,5 kg/m2 and <40 kg/m2
    • Glycated haemoglobin (HbA1c) <48 mmol/mol
    • Kaukasisk etnicitet
    • SeHCAT verificeret moderat til svær galdesyremalabsorption
    • Normal hæmoglobin (mænd 8,3-10,5 mmol/L, kvinder 7,3-9,5 mmol/L)
    • Alder mellem 18 og 75 år
    • Informeret og skriftligt samtykke
    • BMI mellem 18,5 og 40kg/m2
    • Langtidsblodsukker (HbA1c) < 48mmol/mol
    E.4Principal exclusion criteria
    • History of or present hepatobiliary disorder (except for non-alcoholic steatotic liver disease) and/or alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 times upper limit of normal) or history of hepatobiliary disorder
    • Gastrointestinal disease (except for BAM), previous intestinal resection or any major intra-abdominal surgery
    • Diabetes mellitus
    • Nephropathy with eGFR < 30 mL/min/1.73m2
    • Treatment with medicine that cannot be paused for 12 hours
    • Hypothyroidism or hyperthyroidism, if not well regulated.
    • Treatment with oral anticoagulants
    • Active or recent malignant disease
    • Any treatment or condition requiring acute or sub-acute medical or surgical intervention
    • Female of child-bearing potential who is pregnant, breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD) og birth control pills.
    • Known or suspected hypersensitivity to trial products or related products
    • Any condition considered incompatible with participation by the investigators
    • Tidligere eller nuværende leversygdom (dog ikke non-alkoholiske steatotisk lever sygdom) og alanin aminotransferase (ALAT) og/eller aspartate aminotransferase (ASAT) forøget mere end tre gange over normale niveauer.
    • Mave/tarm sygdomme fraset galdesyremalabsorption, resektion af tarmen eller andre store kirurgiske indgreb i mave/tarmkanalen.
    • Sukkersyge
    • Lav nyrefunktion med eGFR < 30mL7min/1,73m2
    • Behandling med medicin som ikke kan pauseres i 12 timer.
    • Ikke reguleret højt eller lavt stofskifte
    • Anti-koagulations behandling
    • Nylige eller aktive maligne sygdomme
    • Behandling eller tilstande som kræver akut eller subakut medicinsk eller kirurgisk behandling
    • Fertile kvinder som ikke bruger prævention i form af medicinsk behandling eller har opsat spiral (IUD)
    • Kendt allergi eller har mistanke om allergi overfor de medikamenter og produkter som bruges i forsøget.
    • Enhver tilstand som ikke findes forenelig med deltagelse af den forsøgsansvarlige læge.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is proportion of patients experiencing response to treatment (i.e. >25% reduction in stool frequency) in the end of the 6-week intervention period; non-inferiority between the two groups. Daily symptom diaries will be used to record stool frequency.
    Det primære end point er andelen af patienter som oplever en effekt af behandlingen , fx reduktion af afføringshyppighed >25%, i de 6 ugers intervention.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be asked to record any adverse events in their symptom diaries. The symptoms diaries will be filled in on a daily basis during weeks -1, 1, 3 and 6.
    Deltagerne fører dagligt dagbog over afføringshyppighed. Dagbøgerne bliver udfyld i ugerne -1, 1, 3 og 6.
    E.5.2Secondary end point(s)
    Secondary endpoints encompass:
    • Stool consistency as assessed by the Bristol Stool-form Scale
    • Proportion of patients experiencing remission of type 2 BAM-related diarrhea (<2 formed or semi-formed stools per day)
    • Symptomatic relief of BAM symptoms as assessed by The Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) and The IBS Severity Scoring System (IBS-SSS)
    • Proportion of patients tolerating treatment (i.e. maintaining treatment throughout the 6-week treatment period) and not tolerating treatment, respectively
    • Change in health-related quality of life score as assessed by SF-36v2(37).
    Further secondary endpoints include
    • Change in percent retention of bile acid (as assessed by SeHCAT) from baseline, proportions of patients 1) improving their BAM severity (from moderate BAM to normal condition or from severe BAM to moderate BAM or normal condition (as assessed by SeHCAT)), 2) experiencing no change in BAM category (as assessed by SeHCAT) and 3) experiencing deterioration in BAM category (i.e. from moderate to severe BAM as assessed by SeHCAT). Of note, SeHCAT results represent exploratory secondary endpoints as BAS treatment - in contrast to liraglutide treatment - is expected to reduce retention of bile acids. For the same reason retention of bile acid as assessed by SeHCAT cannot be used as a primary.
    • Fasting serum/plasma concentrations of total bile acids, fractionated bile acids, cholesterol profile, triglycerides, free fatty acids, C4 (marker of bile acid synthesis), FGF19, glucose, glycated haemoglobin A1c (HbA1c), insulin, C-peptide and glucagon.
    • Faecal content of bile acids and microbiota composition will be evaluated as exploratory endpoints.
    Sekundære end points er;
    • afføringskonsistens, ved brug af bristol stool-form scale,
    • andelen af deltager som oplever reduktion af type 2 galdesyrerelateret diarre
    • reduktion af galdesyremalabsorption-symptomer angivet på ”the gastrointestinal symptom rating scale-IBS” (GSRS-IBS) og ”the IBS severity scoring system” (IBS-SSS)
    • andelen af patienter som tåler og ikke tåler behandlingen
    • ændring i helbreds relateret ændring i livskvalitet ved SF-36v2
    • Ændringer i resultater fra SeHCAT skanninger, dette vil dog ses i gruppen der behandles med aktivt colesevelam, da det forventes at sænke retentionen.
    • Blodprøver taget fastende, herunder totalt frie galdesyrer, fraktionerede galdesyrer, lipid profil, frie fede fedtsyrer, C4 (en markør for galdesyresyntese), FGF-19, langtidsblodsukker, insulin, C-peptid og glukagon.
    • Afføringsprøver mhp. analyse af galdesyrer og mikrobiotisk sammensætning
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionaries: week -1(baseline), 1,3,6
    SeHCAT, blodsamples and faeces samples: Week -1(baseline), 3 and 6
    Spørgeskemaer Uge -1(baseline), 1,3 og 6
    SeHCAT, blodprøver og afføringsprøver: Uge -1 (baseline), 3 og 6
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.1.7.1Other trial design description
    double dummy, non-inferør
    double dummy, non-inferior
    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 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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 10
    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 state50
    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
    None
    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 Decision2018-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-01
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