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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2014-002219-41
    Sponsor's Protocol Code Number:NL49517
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002219-41
    A.3Full title of the trial
    A prospective single-centre double blind randomized study on the efficacy and safety of 4 weekly pasireotide LAR administration in combination with or without weekly pegvisomant in previously controlled acromegaly subjects with combined treatment of long-acting somatostatin analogs and weekly pegvisomant.
    Een prospectieve single-center dubbelblinde gerandomiseerde studie naar de effectiviteit en veiligheid van 4 wekelijks pasireotide LAR in combinatie met wekelijks pegvisomant in patiënten met gecontroleerde acromegalie reeds behandeld met langwerkende somatostatine analogen en wekelijks pegvisomant.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the efficacy and safety of long-acting pasireotide with or without pegvisomant in patients with controlled acromegaly previously treated with long acting somatostatin analogs en weekly pegvisomant.
    Een studie naar de effectiviteit en veiligheid van langwerkend pasireotide met of zonder pegvisomant in patienten gecontroleerd met langwerkende somatostatine analogen en wekelijks pegvisomant.
    A.3.2Name or abbreviated title of the trial where available
    PAPE studie
    A.4.1Sponsor's protocol code numberNL49517
    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 SponsorErasmus Medical Centre
    B.1.3.4CountryNetherlands
    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 supportErasmus Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Centre Rotterdam
    B.5.2Functional name of contact pointA. Muhammad MD PhD candidate
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107038692
    B.5.5Fax number+3110703363
    B.5.6E-maila.muhammad.1@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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 Signifor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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/3/09/670
    D.3 Description of the IMP
    D.3.1Product namePasireotide LAR
    D.3.2Product code SOM230 LAR
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acromegaly
    Acromegalie
    E.1.1.1Medical condition in easily understood language
    Acromegaly
    Acromegalie
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to assess the percentage of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment.
    Het percentage patiënten binnen de leeftijd aangepaste normaalwaarden voor IGF-I met pasireotide LAR (60mg) monotherapie, na 24 weken.
    E.2.2Secondary objectives of the trial
    To assess the percentage of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG-V in patients with an IGF-I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG-V, after 48 weeks of treatment (V8).

    Safety will be assessed based on: adverse events, clinical examination, vital signs, glucose tolerance, EKG, standard hematology, biochemistry, endocrine function tests, GH, PEG-V levels and liver function tests.
    Percentage patiënten met een biochemische normale IGF-I waarden met pasireotide LAR monotherapie na 48 weken behandeling. Het aantal patiënten en de benodigde dosis pegvisomant in patienten met een biochemische normale IGF-I waarden onder behandeling van de combinatie pegvisomant en pasireotide LAR na 48 weken.

    Veiligheid wordt onderzocht op ongewenste voorvallen, lichamelijk onderzoek, vitale functies, glucose tolerantie, ECG, volledig bloedbeeld, biochemie, endocriene testen, GH en PEG-V levels en leverfunctie testen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A written informed consent.
    Male or female age ≥ 18 years.
    The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels.
    The patient is treated with lanreotide Autosolution or octreotide LAR for at least 6 months and has a serum IGF-I level above the 60th percentile and below 1.2 x ULN, 28 days after the last injection.
    ngevulde informed consent formulier.
    Vrouw of man ≥ 18 jaar.
    De patient heeft documentatie waarin is staat dat patient de diagnose acromegalie heeft op basis van verhoogde groeihormoon en/of IGF-I waarden.
    De patient wordt behandeld met combinatie lanreotide Autosolution of octreotide LAR en pegvisomant (tweemaal) wekelijks voor ten minste 6 maanden en de serum IGF-I level moet boven het 60ste percentiel zijn en binnen 1.2 x de upper limit of normal van de leeftijd aangepaste normaalwaarden 28 dagen na de laatste injectie.
    E.4Principal exclusion criteria
    Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
    It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
    Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure.
    Has been treated with any unlicensed drug within the last 30 days before study entry.
    Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 3 ULN).
    Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study.
    Has a history of, or known current, problems with alcohol or drug abuse.
    Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    Renal insufficiency, clearance < 50 ml/min.
    Poorly controlled Diabetes Mellitus with an HbA1c > 9.0%.
    Patients with a QTc > 500 ms on the EKG.
    Participation in a clinical trial in the last 6 months.
    Operatie ondergaan aan de hypofyse of radiotherapie in de afgelopen 6 maanden vooraafgaand aan deelname aan de studie.
    Indien men verwacht dat er tijdens de studie een interventie in de vorm van chirurgie en of radiotherapie noodzakelijk is.
    Overgevoeligheid voor lanreotide, octreotide of pegvisomant of medicatie met een vergelijkbare chemische structuur.
    Behandeling met een ongeregistreerde medicament in de afgelopen 30 dagen voorafgaand aan de studie.
    Abnomale leverfunctie bij studie aanvang (definitie ASAT, ALA, gGT, alkalisch fosfatase or totaal bilirubine meer dan 3 maal bovengrens van normaal.
    Zwangere vrouwen of vrouwen die borstvoeding geven. Vrouwen in de vruchtbare leeftijd dienen een negatieve zwangerschapstest 5 dagen voor de studie te hebben en tijdens de studie anticonceptiva te gebruiken. Niet vruchtbaar potentieel is gedefinieerd als postmenopauzaal voor minstens een jaar, chirurgische sterilizatie of hysterectomie minstens 3 maanden voor de studie.
    Een voorgeschiedenis van drugs of alcoholabusus.
    Een mentale conditie die de proefpersoon belemmeren in begrip van de aard en mogelijke consequenties van de studie en/of bewijs dat een proefpersoon niet goed zou kunnen meewerken.
    Indien er bij het screeningsondezoek een afwijking gevonden wordt die volgens de onderzoeker een probleem voor de studie zouden kunnen geven.
    Nierinsufficientie, klaring < 50 ml/min.
    Slecht gereguleerde diabetes mellitus met een HbA1c > 9.0%.
    Verlengde QTc tijd > 500 ms op de ECG.
    Deelname aan een klinische trials in de afgelopen 6 maanden.
    E.5 End points
    E.5.1Primary end point(s)
    The main study endpoints are the proportion of patients who respond (defined as normalization of IGF-I levels within the age adjusted normal limits) after 24 weeks in the pasireotide LAR monotherapy group and the pasireotide LAR in combination with pegvisomant group.
    De proportie patienten met normalisatie van IGF-I levels na 24 weken in de pasireotide LAR monotherapie groep en de pasireotide LAR met pegvisomant combinatie groep.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 weken
    E.5.2Secondary end point(s)
    To assess the number of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG-V in patients with an IGF-I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG-V, after 48 weeks of treatment (V8).
    The proportion of patients who respond will be calculated along with the exact binomial two-sided 95% confidence interval in each treatment arm. The analysis will be based on the full analysis set.
    Aantal patiënten met een biochemische normale IGF-I waarden met pasireotide LAR monotherapie na 48 weken behandeling. Het aantal patiënten en de benodigde dosis pegvisomant in patienten met een biochemische normale IGF-I waarden onder behandeling van de combinatie pegvisomant en pasireotide LAR na 48 weken.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    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 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) Yes
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    afhankelijk van het IGF1 zal de deelnemer verder gaan in een van de 2 studie armen
    depending on the IGF1 levels subjects will go into 2 different treatment arms
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pegivisomant
    Pegvisomant
    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 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 subject
    laatste visite van de laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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)
    After the trial patients have the option to continue Pasireotide LAR alone or in combination with pegvisomant.
    Na de trial hebben patienten de optie om door te gaan met behandeling met Pasireotide alleen of in combinatie met pegvisomant
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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