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    Summary
    EudraCT Number:2007-002695-34
    Sponsor's Protocol Code Number:CS-201
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-01-21
    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 number2007-002695-34
    A.3Full title of the trial
    A Phase I/II Double-Blind, Dose Ranging, Vehicle Controlled, Randomized, Parallel Groups, Safety, Tolerability and Efficacy Study of ChronSeal® (5-amino-acid deleted recombinant human Hepatocyte Growth Factor (KP-dHGF)), in Subjects with Venous Leg Ulcers
    A.3.2Name or abbreviated title of the trial where available
    Phase I/II Dose Ranging CHRONSEAL® Study in venous leg ulcers
    A.4.1Sponsor's protocol code numberCS-201
    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 SponsorKringle Pharma Europe AB
    B.1.3.4CountrySweden
    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 No
    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 nameChronSeal (50)
    D.3.2Product code n.a.
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5 amino acid deleted recombinant human Hepatocyte Growth Factor
    D.3.9.2Current sponsor codeKP-dHGF
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 typeRecombinant human protein
    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 No
    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 nameChronSeal (10)
    D.3.2Product code n.a.
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5 amino acid recombinant human Hepatocyte Growth Factor
    D.3.9.2Current sponsor codeKP-dHGF
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 typeRecombinant human protein
    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 placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-malignant full skin chronic venous leg ulcers of an area 3 - 20 cm2.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10047260
    E.1.2Term Venous ulceration
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to investigate safety and local tolerance of CHRONSEAL® cream containing 7.1 or 35.7 ng KP-dHGF/g, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.




    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate the treatment effect on ulcer area reduction and changes in ulcer condition of CHRONSEAL® cream, containing 7.1 or 35.7 ng KP-dHGF/g, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    RUN-IN PERIOD
    INCLUSION CRITERIA - SUBJECT
    1. Caucasian male or clinically sterile female subjects (postmenopausal > 12 months (confirmed as FSH > 30 mU/ml if in doubt), hysterectomy or tubal ligation)
    2. 40 years or older.
    3. Ankle brachial index of at least 0.6.
    4. Written informed consent obtained, and a copy provided to the subject.
    5. Subject legally competent and able to communicate effectively with the study personnel.
    6. Subject likely to co-operate.

    INCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil the inclusion criteria)
    7. Uncomplicated venous ulcer as by clinical diagnosis.
    8. Full skin ulcer.
    9. Localisation above the foot and below the knee (wrist and malleole included)
    10. Duration of at least 3 months.
    11. Area 3-20 cm2.

    RANDOMISATION (after fulfilled run-in period)
    INCLUSION CRITERIA - SUBJECT
    1. Subject likely to co-operate.

    INCLUSION CRITERIA - TARGET ULCER
    2. Ulcer area reduction less than 50% during run-in period.
    3. Ulcer area 3-20 cm2.
    E.4Principal exclusion criteria
    RUN-IN PERIOD
    EXCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil inclusion criteria)
    1. Visible signs of infection, black necrosis or discharge in the target ulcer.
    2. More than ~20% slough after debridement.
    3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol e.g. placement difficult for photography, multiple close ulcers, or tissue undermining/sinus tracts.
    4. Other known etiology of the target ulcer e.g. malignancy, vasculitis or severe clinical overt ischemia.

    EXCLUSION CRITERIA - SUBJECT
    5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.
    6. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.
    7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
    8. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:
    • NSAIDs, aspirin
    • Growth factors, or other biologically active agents
    • Products containing chlorhexidine, potassium permanganate, iodine or silver
    9. Diabetes Mellitus requiring pharmaceutical treatment.
    10. Co-morbidity with a life expectancy less than 6 months.
    11. Co-morbidity expected to lower compliance.
    12. Diagnosed kidney disease
    13. Individuals sensitive to any of the study medication components.
    14. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.
    15. Known abuse of alcohol, drugs or pharmaceuticals.
    16. Diagnosis of invasive squamos epithelia carcinoma
    17. Diagnoses of a serious psychiatric illness which may influence study participation.

    RANDOMISATION (after fulfilled run-in period)
    EXCLUSION CRITERIA - TARGET ULCER
    1. Visible signs of infection, black necrosis or discharge in the target ulcer.
    2. More than ~20% of the ulcer area slough after debridement.

    EXCLUSION CRITERIA - SUBJECT
    3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.
    4. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.
    5. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
    6. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:
    • NSAIDs, aspirin
    • Growth factors, or other biologically active agents
    • Products containing chlorhexidine, potassium permanganate, iodine or silver
    7. Co-morbidity expected to lower compliance.
    8. Diagnosed kidney disease.
    9. Individuals sensitive to any of the study medication components.
    10. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.
    E.5 End points
    E.5.1Primary end point(s)
    Primary study endpoints
    • Safety (number and type of adverse events)
    • Local tolerance






    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 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerance, Health economy
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.3 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 concerned12
    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 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 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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 40
    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)
    n.a.
    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 Decision2009-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-03-01
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