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    Summary
    EudraCT Number:2004-002122-22
    Sponsor's Protocol Code Number:02-VLU-003
    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:2005-05-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-002122-22
    A.3Full title of the trial
    A prospective, multi-centre, double blind, randomized, placebo controlled trial to evaluate the safety and efficacy of ICXP007 in a phase III trial with four-layer therapeutic compression, for treatment of non-infected skin leg ulcers, due to venous insufficiency.
    A.3.2Name or abbreviated title of the trial where available
    TOPICAL II
    A.4.1Sponsor's protocol code number02-VLU-003
    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 SponsorIntercytex Limited
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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.3.2Product code ICXP007
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHuman Dermal Fibroblasts
    D.3.10 Strength
    D.3.10.3Concentration number3 x 10e6 cells
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous Insufficiency Leg Ulcers
    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
    To evaluate the safety and efficacy of ICXP007 in achieving 100% closure of non-infected skin ulcers of greater than 3 months duration due to venous insufficiency with four layer bandage compression therapy.
    E.2.2Secondary objectives of the trial
    To compare four layer compression bandaging plus ICXP007 against both four layer compression bandaging plus placebo and the use of four layer compression bandaging alone in the treatment of non-infected skin ulcers due to chronic venous insufficiency.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TOPICAL II: SUB-STUDY ADDENDUM

    A PROSPECTIVE, MULTI-CENTRE, DOUBLE BLIND, RANDOMIZED, PLACEBO
    CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ICXP007
    IN A PHASE III TRIAL WITH FOUR-LAYER THERAPEUTIC COMPRESSION, FOR THE
    TREATMENT OF NON-INFECTED SKIN LEG ULCERS, DUE TO VENOUS-INSUFFICIENCY

    Addendum v02, 14 Jan 08

    To evaluate the safety and efficacy of ICXP007 in a Phase III trial with standard four-layer bandage compression therapy, for the treatment of non-infected skin ulcers of greater than 3 months duration due to venous-insufficiency. Additional to assess the persistence of human dermal fibroblasts if patients treated with ICXP007.
    E.3Principal inclusion criteria
    1. Individuals who have a graft-ready venous leg ulcer of at least 3 months duration, which has not, responded to standard conventional therapy.
    2. Individuals who have an Ankle Brachial Pressure Index (ABPI/ABI) of greater than or equal to 0.8 measured by Doppler sonography.
    3. Individuals who have venous incompetency as defined by > 1.0 seconds in vein segments on standing reflux exam by duplex or an abnormal venous refill time of < 21 seconds by PPG or > 2 cc per second by APG. Duplex or PPG/APG will be used to establish venous insuffciency. Doppler will be utilized to rule out arterial disease.
    4. Individuals who have a target wound which is between 2 cm squared to 20 cm squared in area at the screening assessment.
    5. Individuals who are ambulatory.
    6. Individuals who have voluntarily signed and dated a patient Informed Consent Form (ICF).
    7. Individuals, who are, in the opinion of the investigator, able to understand this study, co-operate with teh study procedures and are willing to return to the clinci for all the required follow-up visits.
    8. Sub-study only: Patients who are Female
    9. Sub-study only: Have a coagulation profile which, in the opinion of the Investigator, would not result in excessive bleeding during biopsy procedure

    E.4Principal exclusion criteria
    1. Indiviudals with a known hypersensitivity to Aprotinin or any other constitutents of Tisseel VH S/D, i.e. fibrinogen (human), thrombin (human) and calcium chloride, bovine and porcine products.
    2. Individuals who have a haemoglobin or serum albumin level which is < 10 g / dL or < 2.5 g / dL respectively, or is otherwise outside the normal range and deemed clinically significant.
    3. Females who are pregnant, lactating, or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the Investigator for the duration of the study.
    4. Individuals younger than 18 years of age.
    5. Individuals with abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range and / or any other abnormal laboratory finding considered clinically significant.
    6. Individuals who have exposed bone, tendon or fascia visible around the target wound.
    7. Individuals with evidence of collagen vascular diseases, such as vasculitis or rheumatiod arthritis, under active treatment.
    8. Individuals with evidence of cellulitis or osteomyelitis during the previous 4 weeks.
    9. Individuals who have a target wound which shows signs of clinical infection or the Investigator suspects may be severly infected.
    10. Individuals who have any clinically significant medical condition that would impair wound healing as determined by the investogator, including uncontrolled diabetes as determined by HbA1C (>12%), or immune disease.
    11. Individuals who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.
    12. Individuals who have chronic renal insufficiency requiring haemodialysis.
    13. Individuals who have received short course corticosteriods within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
    14. Individuals who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.
    15. Individuals who have participated in a clinical study of any investigational product within 2 months prior to treatment.
    16. Individuals who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
    17. Individuals previously enrolled/randomized in this clinical trial.
    18. Sub-study only: Individuals who have a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
    19. Individuals who have an abnormal PT, PTT or platelet value defined as 1.5 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant.
    20. Sub-study only: Individuals who are taking more than 2 tablets of 81 mg Aspirin per day or any dose of Coumadin on a regular basis.
    E.5 End points
    E.5.1Primary end point(s)
    Healing assessed by incidence of 100% closure (epithelialised) as determined by the investigator, at any time during the initial 12 weeks of the treatment period.

    This must be confirmed 2 weeks later in order to be classified as closure.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    E.8.2.3.1Comparator description
    standard therapy (4 layer compression bandaging)
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 patient last visit
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 412
    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 Decision2005-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-19
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