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    Summary
    EudraCT Number:2008-006863-35
    Sponsor's Protocol Code Number:314759
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-006863-35
    A.3Full title of the trial
    Prophylactic photodynamic therapy for organ transplant patients – a
    randomised, intra-individual trial with blinded outcome evaluation.
    Profylaktisk fotodynamisk terapi för organtransplanterade patienter en
    randomiserad, intra individuell studie med blindad effektutvärdering.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic photodynamic therapy for organ transplant patients.
    Profylaktisk fotodynamisk terapi för organtransplanterade patienter.
    A.4.1Sponsor's protocol code number314759
    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 SponsorBispebjerg 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 supportBispebjerg Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBispebjerg Hospital
    B.5.2Functional name of contact pointMerete Haedersdal
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg bakke 23
    B.5.3.2Town/ cityKöpenhamn NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+453531 60 02
    B.5.6E-mailmhaedersdal@dadlnet.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 Metvix creme
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Nordic AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameMetvix
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    Development of actinic keratoses and skin cancer in kidney transplant patients - a randomised, intra-individual trial with blinded outcome evaluation.
    Utveckling av aktiniska keratoser och hudcancer hos njurtransplanterade patienter en randomiserad, intra individuell studie med blindad effektutvärdering.
    E.1.1.1Medical condition in easily understood language
    Development of actinic keratoses and skin cancer in kidney transplant patients.
    Utveckling av aktiniska keratoser och hudcancer hos njurtransplanterade patienter.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10040808
    E.1.2Term Skin cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10047829
    E.1.2Term Warts (viral)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Number of new skincancer and actinic keratoses in PDT-treated side in relative to untreated side.
    Antal av nytillkomna hudcancer och aktiniska keratoser på
    PDT-behandlad sida i relation till obehandlad sida.
    E.2.2Secondary objectives of the trial
    New warts in PDT-treated side in relative to un-treated control.
    Antal nya vårtor på PDT-behandlad sida i förhållande till obehandlad
    kontroll.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who have undergone a kidney transplant at least 1 year ago.
    Patients who have given written informed consent and are considered willing to follow the trial protocol.
    Patients aged 40 years or older.
    Patients with fair skin type defined as Fitzpatrick skin type I-III.
    Fertile women must use a reliable form of contraception.
    Patienter som för minst ett år sedan genomgått njurtransplantation.
    Patient som har givit sitt skriftliga samtycke att delta och antas vilja följa studieprotokollet.
    Patienter över 40 år och äldre.
    Patienter med ljus hudtyp definierad som Fitzpatrick hudtyp I-III.
    Fertila kvinnor måste använda säkert preventivmedel.
    E.4Principal exclusion criteria
    Patients under 40 and over 70 years of age.
    Patients who have received PDT treatment in the areas under
    investigation.
    Patients with dark skin type defined as Fitzpatrick skin type IV-VI.
    Patients, have signs of dysplastic skin changes in the areas
    under investigation, such as warts, AK, NMSC, Bowen's disease,
    keratoacanthoma or infiltrative tumours.
    Patients known to have an allergy to any constituents of the MAL cream
    Pregnant or breast-feeding patients.
    Patienter under 40 och över 70 års ålder.
    Patienter som har fått PDT behandling på de undersökta områdena som
    skall undersökas.
    Patienter med mörk hud definierad som Fitzpatrick hudtyp IV-VI.
    Patienter med tecken på dysplastiska förändringar i områdena
    som skall undersökas så som vårtor, AK, NMSC.
    Allergi mot något innehåll i MAL krämen
    Gravida och ammande patienter.
    E.5 End points
    E.5.1Primary end point(s)
    Number of newly developed AK or skin cancer in the treatment areas
    Antal nyutvecklade AK eller hudcancer i behandlingsområdena
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60 månader efter första PDT.
    E.5.2Secondary end point(s)
    Number of newly developed viral warts
    Adverse effects such as pigmentary changes and scar
    Degree of photodamage and cosmetic outcome
    Antal nyutvecklade virus vårtor i behandlingsområdet
    Biverkningar så som som pigmentförändringar, ärr
    Grad av solskador och kosmetiskt resultat
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60 månader efter första PDT.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ingen behandling
    No treatment
    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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Norway
    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
    Sista visiten för sista patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 50
    F.1.3Elderly (>=65 years) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 50
    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)
    All patients, who complete or withdraw from the study, are offered follow-up and treatment, if any skin disorders, at the department of Dermatology at Sahlgrenska Universitetssjukhus. Patients will be treated as normal outpatient referrals.
    Alla patienter, som fullföljer eller utträder ur studien erbjuds uppföljning och behandling om någon hudsjukdom uppstår, vid avdelningen för Dermatologi (hudkliniken) på Sahlgrenska universitetssjukhuset. Patienterna kommer att behandlas som vanliga öppenvårds patienter.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-01
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