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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2008-001603-30
    Sponsor's Protocol Code Number:RD.03.SPR.29061
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-001603-30
    A.3Full title of the trial
    Gene expression in renal transplant patients with field Actinic Keratosis undergoing Metvix® PDT
    A.3.2Name or abbreviated title of the trial where available
    Metvix® PDT
    A.4.1Sponsor's protocol code numberRD.03.SPR.29061
    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 SponsorGalderma R&D
    B.1.3.4CountryFrance
    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 Metvix® 160 mg/g cream
    D.2.1.1.2Name of the Marketing Authorisation holderPhotoCure ASA
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 160 mg/g cream
    D.3.2Product code P 1202
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 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
    Renal transplant male or female subjects, aged at least 18 years old, with history of immunosuppression from 5 to 15 years, and with a diagnosis of field actinic keratosis on face, scalp, forearms or chest (minimum of 4 discrete mild or moderate AKs) and meeting other specific inclusion/exclusion criteria.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix® Photodynamic therapy (PDT) of Actinic Keratoses (AK) and cancerised field in renal transplant recipients. It will be studied if Metvix® reduces the number of molecular aberrations leading to epidermal neoplasia in the treated area. Both the treatment effect [on existing lesions (actinic keratoses)] and the prophylactic effect (prevention of appearance of new lesions) will be measured and linked to the effect on gene expression.
    E.2.2Secondary objectives of the trial
    In addition to the main objectif the Investigator will assess at each evaluation visit after baseline all clinical actinic keratosis lesions' response to the procedure, within the target field, as follows : clear or not completely clear lesion (including new and recurrent lesions).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Renal transplant male or female subject, aged at least 18 years old, with an history of immunosuppression from 5 to 15 years,
    - Subject presenting field of mild or moderate AKs with at least 4 discrete mild or moderate AK lesions on the face, scalp, forearms or chest ,
    - Female of child-bearing potential with negative urinary pregnancy test at the beginning of the study and who practices a highly effective method of contraception all along the study and female of non childbearing potential,
    - Subject able to follow study instructions and likely to complete all required visits.
    E.4Principal exclusion criteria
    - Female subject who is pregnant, or of child-bearing potential and wishing to become pregnant during the study, or is breast feeding,
    - Subject who is at risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
    - Subject with thick AK lesions on the target field,
    - Subjects with pigmented AK(s) on the target field,
    - Subject with AK lesions clinically atypical or suspicious for malignancy on the target field,
    - Subject presenting other skin lesions (including non melanoma skin cancers) on the target field,
    - Subject with suspected porphyria,
    - Subject with a bad skin condition (eczema, rosacea, acne, atopic dermatitis, psoriasis…) in the target field or who is in a situation which, in the investigator’s opinion , may put the subject at risk, may confound the study results, or may interfere with the subject’s participation in the study,
    - Subject who has been treated in the target field with any of the following topical treatments within the specified washout period at Screening:
    . 5-FU, Imiquimod, Diclofenac sodium: 3 months
    . Cryotherapy: 3 months
    . PDT: 3 months
    . Other less common AK treatments: 3 months
    - Subject who has been treated with systemic retinoids within the last month prior to Screening visit,
    - Subject with known HIV or chronic hepatitis B and/or C (To be confirmed based on previous blood analysis done at a maximum within 3 months prior to the Screening visit or, if not available will be confirmed at Baseline with blood sample results performed at Screening),
    - Subject who has participated in another investigational drug or device research study within 30 days of enrolment (screening visit),
    - Subject requiring concurrent treatment that would interfere with study objectives and/or evaluations,
    - Adult protected by the law (adult under guardianship, or hospitalised in a public or private institution for a reason other than the study, or subject deprived of freedom),
    - Subject who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
    E.5 End points
    E.5.1Primary end point(s)
    Week 18
    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 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 Yes
    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 No
    E.8.1.2Open No
    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 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 No
    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 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 months6
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-08-19. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    renal transplant patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Once the study has ended the patient will normally no longer be provided with the trial drug free by a pharmaceutical company. The patient may then be offered alternative treatments (or none, if the treatment were ineffective), if the study Doctor finds this necessary. The patient will not be without treatment should a treatment be effective, but that treatment may not be the trial drug.
    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 Decision2008-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-07
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