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    Summary
    EudraCT Number:2006-000961-12
    Sponsor's Protocol Code Number:ML20240
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-000961-12
    A.3Full title of the trial
    Prospective study to investigate if patients on reduced-dose EC-MPS treatment due to gastrointestinal problems can be switched to a higher than the equimolar dose of MMF
    A.4.1Sponsor's protocol code numberML20240
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoche Pharma AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CellCept 250 mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd., Welwyn, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCellCept 250 mg capsules
    D.3.2Product code S-61443, RO106-1443
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycophenolate mofetil
    D.3.9.2Current sponsor codeS-61443, RO106-1443
    D.3.9.3Other descriptive nameMMF
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressant agents
    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 CellCept 500 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd., Welwyn, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCellcept 500 mg tablets
    D.3.2Product code S-61443, RO106-1443
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMycophenolate mofetil
    D.3.9.2Current sponsor codeS-61443, RO106-1443
    D.3.9.3Other descriptive nameMMF
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressant agents
    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
    In diese Studie sollen erwachsene nierentransplantierte Patienten eingeschlossen werden, die aufgrund von gastrointestinalen Beschwerden eine geringere als die empfohlene Tagesdosis von 1440 mg EC-MPS erhalten. Es handelt sich um Patienten, die seit mindestens 6 Monaten eine Therapie mit EC-MPS bekommen, wobei die EC-MPS Dosis innerhalb den letzten 2 Monate vor Studienbeginn unverändert sein soll.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Das Hauptziel der Prüfung ist der Nachweis, dass Patienten von EC-MPS auf eine höhere als die äquivalente Dosis MMF umgestellt werden können, ohne dass es zu einer Verschlechterung der Lebensqualität kommt.
    E.2.2Secondary objectives of the trial
    Ein sekundäres Ziel ist die Untersuchung der Predose-Konzentrationen, d.h vor der morgentli-chen Einnahme, von MPA, MPAG und AcMPAG vor und nach der Therapieumstellung, um einen möglichen Zusammenhang der Plasmakonzentration von MPA oder dessen Metaboliten und dem Auftreten von gastrointestinalen Nebenwirkungen erkennen zu können.
    Als weiteres sekundäres Ziel soll die Sicherheit und Wirksamkeit der Umstellung und Dosis-erhöhung unter Aufteilung der Tagesdosis untersucht werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patienten nach Nierentransplantation
    • Alter ≥ 18
    • Patienten, die aufgrund von GI Problemen weniger als die empfohlene EC-MPS Dosis von 1440 mg/Tag erhalten
    • Therapie mit EC-MPS seit mindestens 6 Monaten
    • Stabile EC-MPS Dosis in den letzten 2 Monaten
    • Erst- oder Zweittransplantation
    • Bereitschaft zur schriftlichen Einwilligung nach Aufklärung, schriftliche Einwilligung zur Teilnahme an der klinischen Prüfung inklusive datenschutzrechtlicher Einwilligung und zur Einhaltung der Studienbedingungen.
    E.4Principal exclusion criteria
    • aktives gastrointestinales Ulcus
    • schwere Diarrhoe oder gastrointestinale Erkrankungen, die die Resorption von Medikamenten beeinträchtigen
    • Serumkreatinin > 2,5 mg/dl
    • Glomeruläre Filtrationsrate < 25 mg/min/1,73 m²
    • Anämie Hb <7 g/dl oder Leukozytopenie <3000/ml³ oder Thrombozytopenie <80 000/ml³
    • aktive Infektion
    • aktive Hepatitis oder Pankreatitis
    • HIV oder Hepatitis B (sAg) oder C-positiv
    • Maligne Erkrankung
    • Lesch-Nyhan- oder Kelley Seegmiller-Syndrom
    • Gleichzeitige Teilnahme an einer anderen klinischen Prüfung oder Teilnahme an einer anderen klinischen Prüfung innerhalb der letzten 30 Tage.
    • Einnahme von nicht zugelassenen Immunsuppressiva
    • Patient ist bereits einmal in diese Studie aufgenommen worden.
    • Stillende Frauen, Schwangere oder Frauen im gebärfähigen Alter, die keine hoch effektive Methode der Kontrazeption praktizieren "(erlaubte Methoden der Kontrazeption, d.h. mit einer Versagerquote von weniger als 1 % pro Jahr, sind Implantate, Injektionspräparate, kombinierte orale Kontrazeptiva, Intrauterinpessare (nur Hormonspiralen), sexuelle Abstinenz oder Vasektomie des Partners). Der Schwangerschaftstest (Serum oder Urin) an Visite 1 (Baseline) muss bei Frauen im gebärfähigen Alter negativ sein."
    • Minderjährige Personen oder volljährige Personen, die nicht in der Lage sind, Wesen, Bedeutung und Tragweite der klinischen Prüfung zu erkennen und ihren Willen hiernach auszurichten (gemäß § 40 Abs. 4 und § 41 Abs. 2 und Abs. 3 AMG)
    • Anamnestisch bekannte oder aktuelle psychische Erkrankung oder Störung, die die Fähigkeit des Patienten beeinträchtigen kann, die Anforderungen der Prüfung zu verstehen.
    • Betroffene Personen, die vom Sponsor oder Prüfer möglicherweise abhängig sind.
    • Betroffene Personen, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht sind (gemäß § 40 Abs. 1 S. 2 Nr. 4 AMG).
    E.5 End points
    E.5.1Primary end point(s)
    Prozentualer Anteil der Patienten, die von EC-MPS auf eine höhere Dosis als die äquivalente Dosis umgestellt werden können, ohne dass es zu einer Verschlechterung der Lebensqualität kommt.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    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 Information not present in EudraCT
    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
    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 months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state100
    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)
    Die Weiterbehandlung der Patienten nach Studienende erfolgt im Rahmen der Routineversorgung. Die Folgebehandlung, einschließlich eventueller weiterer Dosiserhöhungen von MMF liegt in der Verantwortung des behandelnden Arztes und erfolgt nach Maßgabe des behandelnden Arztes.
    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 Decision2006-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-10-31
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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