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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001067-23
    Sponsor's Protocol Code Number:PasHypo
    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:2018-04-05
    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 number2018-001067-23
    A.3Full title of the trial
    Pasireotide in the treatment of hypoglycemia following gastric bypass surgery
    Pasireotid i behandlingen af hypoglykæmi efter gastric bypass
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pasireotide in the treatment of low blood sugar following gastric bypass surgery
    Pasireotid i behandlingen af lavt blodsukker efter gastric bypass
    A.4.1Sponsor's protocol code numberPasHypo
    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 SponsorZealand University Hospital
    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 supportZealand University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand University Hospital
    B.5.2Functional name of contact pointCaroline Øhrstrøm
    B.5.3 Address:
    B.5.3.1Street AddressLykkebækvej 1
    B.5.3.2Town/ cityKøge
    B.5.3.3Post code4600
    B.5.3.4CountryDenmark
    B.5.6E-mailcacg@regionsjaelland.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 Signifor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Health Care 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPASIREOTIDE DIASPARTATE
    D.3.9.1CAS number 396091-73-9
    D.3.9.4EV Substance CodeSUB71450
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 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 Signifor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Health Care 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPASIREOTIDE DIASPARTATE
    D.3.9.1CAS number 396091-73-9
    D.3.9.4EV Substance CodeSUB71450
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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
    Postprandial reactive hypoglycemia in patients with prior Roux-en-Y
    gastric bypass surgery.
    Postprandial reaktiv hypoglykæmi hos patienter tidligere opereret med
    Roux-en-Y gastric bypass
    E.1.1.1Medical condition in easily understood language
    Low blood sugar in patients with prior gastric bypass surgery
    Lavt blodsukker hos patienter med tidligere gastric bypass operation.
    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 10059038
    E.1.2Term Postprandial hypoglycemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of both 75 ug pasireotide (P75) and 150 ug pasireotide (P150) on the postprandial blood glucose response in RYGB operated patients with hypoglycemia.
    At undersøge effekten af hhv. 75 og 150 ug pasireotid på det postprandiale blodglukoserepons hos RYGB opererede patienter med hypoglykæmi.
    E.2.2Secondary objectives of the trial
    - To compare the effects of P75 and P150 on the postprandial blood glucose response with the effects of 300 ug pasireotide (P300) and a baseline recording with no treatment (NT) (results from a prior study with the same study participants).
    - to investigate the effects of P75 and P150 on the postprandial secretion of insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine and epinephrine, and to compare these effects with the effects of P300 and NT on the same parameters (results from a prior study with the same study participants).
    - At sammenligne effekten af pasireotid 75 µg (P75) og pasireotid 150 µg (P150) på det postprandiale blodglukoserespons med effekten af pasireotid 300 µg (P300) og ’Run-in’ (baseline optagelse uden behandling (NT)) på det postprandiale blodglukoserespons (resultater fra et tidligere forsøg med de samme forsøgsdeltagere).
    - At undersøge effekten af P75 og P150 på den postprandiale sekretion af insulin, C-peptid, GLP-1, glukagon, IGF-1, noradrenalin og adrenalin, og sammenligne denne med effekten af P300 og NT på tilsvarende effektmål (resultater fra et tidligere forsøg med de samme forsøgsdeltagere).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Prior participation in our study 'Treatment of hypoglycemia following gastric bypass surgery (EudraCT 2015-001086-50).
    hemoglobin > 7,3 mmol/L,
    Age 20-60 years
    Normal ECG
    Tidligere deltagelse i vores forsøg 'Behandling af hypoglykæmi efter gastric bypass' (EudraCT 2015-001086-50)
    Hæmoglobin > 7,3 mmol/L
    Alder 20-60 år
    Normalt EKG
    E.4Principal exclusion criteria
    pregnancy, breastfeeding, allergic reactions to the study medicine, treatment for cardiovascular disease, treatment for thyroid disease, treatment with antipsychotica or trycyclic antidepressants, impaired liver function (Child Pugh C)
    graviditet, amning, overfølsomhed for forsøgslægemidlet, behandling for hjerte-karsygdom, behandlingskrævende stofskiftesygdom, behandling med antipsykotika eller tricykliske antidepressiva, svært nedsat leverfunktion (Child Pugh C)
    E.5 End points
    E.5.1Primary end point(s)
    The postprandial blood glucose response for P75 and P150, defined as the incremental area under the curve for glucose (iAUCglucose)
    Det postprandiale blodglukoserepons defineret som det inkrementale areal under kurven for glukose (iAUCglukose) for hhv. P75 og P150.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Ved forsøgets afslutning
    E.5.2Secondary end point(s)
    - nadir glucose, peak glucose, time in hyperglycemia (time with glucose values ≥7,8 mmol/l) and time in hypoglycemia (time with glucose values ≤3,9 mmol/l) for both P75 and P150.
    - Area under the curve for insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine, epinephrine (AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine) for both P75 og P150.
    - Changes in heart rate (HR) and blood pressure (BP) for both P75 and P150.
    - Comparison of iAUCglucose, nadir glucose, peak glucose, time in hyperglycemia, time in hypoglycemia, AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine, HR and BP for P75 and P150 with the same parameters for P300 and NT (results from a prior study with the same study participants).
    - Nadir glukose, peak glukose, tid i hyperglykæmi (defineret som tid med glukoseværdier ≥7,8 mmol/l) og tid i hypoglykæmi (defineret som tid med glukoseværdier ≤3,9 mmol/l) for hhv. P75 og P150.
    - Arealet under kurven for insulin, C-peptid, GLP-1, glukagon, IGF-1, noradrenalin, adrenalin (AUCinsulin, AUCC-peptid, AUCGLP-1, AUCglukagon, AUCIGF-1, AUCnoradrenalin, AUCadrenalin) for hhv. P75 og P150.
    - Ændringer i hjertefrekvens (HF) og blodtryk (BT) under måltidstestforsøget for hhv. P75 og P150.
    - Sammenligning af iAUCglukose, nadir glukose, peak glukose, tid i hyperglykæmi, tid i hypoglykæmi, AUCinsulin, AUCC-peptid, AUCGLP-1, AUCglukagon, AUCIGF-1, AUCnoradrenalin, AUCadrenalin, HF og BT for P75 og P150 med tilsvarende effektmål for P300 og NT (resultater fra tidligere forsøg)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Ved forsøgets afslutning
    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 No
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Samme lægemiddel, men i en anden dosis
    same medicinal product, but different dose
    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
    Sidste deltagers sidste besøg
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    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: 5
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    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
    Ingen
    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 Decision2018-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-13
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