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    Summary
    EudraCT Number:2012-000603-32
    Sponsor's Protocol Code Number:NL3364409612
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-16
    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 number2012-000603-32
    A.3Full title of the trial
    Proton pump inhibitors in the prevention of iron reaccumulation in patients with hereditary hemochromatosis
    Maagzuurremmers ter voorkoming van ijzerstapeling bij patienten met erfelijke ijzerstapeling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proton pump inhibitors in the prevention of iron reaccumulation in patients with hereditary hemochromatosis
    Maagzuurremmers ter voorkoming van ijzerstapeling bij patienten met erfelijke ijzerstapeling.
    A.3.2Name or abbreviated title of the trial where available
    He-ppi
    A.4.1Sponsor's protocol code numberNL3364409612
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01524757
    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 SponsorAnnadalstichting
    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 supportAnnadal Stichting
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University of Maastricht
    B.5.2Functional name of contact pointGer Koek
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 5800
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6202AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310433875021
    B.5.6E-mailgh.koek@mumc.nl
    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 pantoprazol; Pantomed
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namepantomed
    D.3.2Product code RVG 22106
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpantoprazole
    D.3.9.1CAS number 164579-32-2
    D.3.9.3Other descriptive namePANTOPRAZOLE SODIUM SESQUIHYDRATE
    D.3.9.4EV Substance CodeSUB21564
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    D.8.4Route of administration of the placeboGastroenteral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary hemochromatosis
    Erfelijke hemochromatose
    E.1.1.1Medical condition in easily understood language
    Hereditary iron reaccumulation
    Erfelijke ijzerstapeling
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The difference between the number of phlebotomies (expressed as standardized units 500ml-per year) for the group taking ppi treatment compared to the group taking placebo
    Wat is het verschil in aantal aderlatingen bij patienten met herediataire hemochromatose die behandeld worden met ppi in vergelijking met placebo?
    E.2.2Secondary objectives of the trial
    To determine quality of life (questionnaires), cost effectiveness (QUALY), patient compliance/ satisfaction, side effects due to phlebotomies and ppi.
    Wat is de kwaliteit van leven? Wat is de kosteneffectiviteit bij het gebruik van ppi in de behandeling bij patienten met hemochromatose? Wat is de patienttevredenheid/ compliance? Wat zijn de bijwerkingen bij het gebruik van ppi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient with hereditairy hemochromatosis, homozygous for c282Y currently treated with phlebotomy as maintenance therapy for at least 12 months with >/= phlebotomies per year.
    Ferritin level between 50-100 ug/l at start of inclusion.
    Age 18-75 years
    Weight > 50kg
    Patienten met erfelijke hemochromatose, homozygoot voor c282Y die momenteel met flebotomie als onderhoudstherapie worden behandeld voor minimaal 12 maanden met >/= 3 flebotomien per jaar.
    Op moment van inclusie ferritine tussen 50-100 ug/l
    Leeftijd 18-75 jaar
    Gewicht > 50kg
    E.4Principal exclusion criteria
    Patients receiving other therapies such as chelating therapy or forced diet
    Obesitas (BMI > 35)
    Patients who are mentally incapacitated
    pregnancy; women expecting / planning to become pregnant during the study period.
    Patients with a malignancy
    Patients already on ppi treatment
    patients experienced side effects ppi.
    Patienten welke een alternatieve behandeling ontvangen zoals chelatie of een geforceerd dieet.
    Obesitas (BMI > 35)
    Wilsonbekwame patienten
    Zwangerschap; te verwachten of geplande zwangerschap ten tijde van studieduur
    patienten met een maligniteit
    Patienten die reeds een ppi gebruiken.
    Patienten die bijwerkingen van een ppi rapporteerden
    E.5 End points
    E.5.1Primary end point(s)
    Number of phleobotomies (expresses as standardized units-500ml-per year)
    Aantal aderlatingen (uitgedrukt in gestandaardiseerde eenheden van 500ml per jaar)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 months
    Na 12 maanden
    E.5.2Secondary end point(s)
    To determine quality of life (questionnaires), cost effectiveness (QUALY), patient compliance/ satisfaction, side effects due to phlebotomies and ppi.
    Wat is de kwaliteit van leven? Wat is de kosteneffectiviteit bij het gebruik van ppi in de behandeling bij patienten met hemochromatose? Wat is de patienttevredenheid/ compliance? Wat zijn de bijwerkingen bij het gebruik van ppi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 12 months
    Na 12 maanden
    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 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 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 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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
    Geen
    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 Decision2012-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-01
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