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    Summary
    EudraCT Number:2011-001284-44
    Sponsor's Protocol Code Number:MEDLARV-CLIN-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-04-15
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-001284-44
    A.3Full title of the trial
    A RANDOMIZED, OPEN, SELF-CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF LARVAL THERAPY IN PATIENTS WITH LEG ULCERS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL OF LARVAL THERAPY IN PATIENTS WITH LEG ULCERS
    A.3.2Name or abbreviated title of the trial where available
    CLINICAL TRIAL OF LARVAL THERAPY OF LEG ULCERS
    A.4.1Sponsor's protocol code numberMEDLARV-CLIN-01
    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 SponsorMAGGOT 2006 Egészségügyi, Kereskedelmi és Szolgáltató Ltd.
    B.1.3.4CountryHungary
    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 supportMaggot 2006 Ltd.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaggot 2006 Ltd.
    B.5.2Functional name of contact pointMedLarv Thehapy Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressJankovics u 14.
    B.5.3.2Town/ citySzeged
    B.5.3.3Post code6726
    B.5.3.4CountryHungary
    B.5.4Telephone number36704522119
    B.5.5Fax number3662406006
    B.5.6E-mailmaggotherapy@gmail.com
    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 nameMedLarv
    D.3.4Pharmaceutical form Cutaneous liquid
    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 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) 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.3.11.13.1Other medicinal product typeMedLarv is Lucilia sericata sterile live larvae as a special, live, animal origin product, which derives from the stage 1 life cycle of Lucilia sericata green blow fly.
    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
    Venous or mixed venous/arterial ulcers
    E.1.1.1Medical condition in easily understood language
    Venous leg ulcers develop as the result of underlying venous disease and usually take months to heal.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 compare the clinical effectiveness of larval therapy with a standard debridement technique Hydrogel in terms of 75% of clearing of ulcers in patients after (maximum five courses) of larval therapy.
    E.2.2Secondary objectives of the trial
    • To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) in terms of its effect on time to debridement of leg ulcers.
    • To compare the clinical effectiveness of larval therapy with a standard debridement technique hydrogel in terms of % of clearing, after (maximum five course ) larval therapy.
    • To compare the effect of larval therapy and hydrogel on bacterial load
    • Safety and tolerability of larval therapy
    • Health-related quality of life (including ulcer-related pain) SF-12 and EQ-5D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients aged between 18 and 85 years inclusive with venous or mixed venous/arterial ulcers
    • Minimum ankle brachial pressure index (ABPI) equal to or more than 0.8
    • Minimum of 25% of ulcer area covered by slough and/or necrotic tissue
    • Patients with ulcers with an area of (30-70) cm2 (and the ulcer was not healing (‘not healing’ defined as no measurable change in area over one month preceding assessment). The ulcer for larval and hydrogel terapy could be selected from one leg or both legs. One of the ulcers will serve for larval therapy: ” reference ulcer” and the other one for Hydrogel therapy: ”control ulcer”.
    • Patients with at least two ulcers with an area of 30-70 cm2 (using one ulcer for active and one for control hydrogel treatment); within each patient the difference between two ulcers should not exceed 10 cm2.
    • Male patients
    • Female patients must either be
    -Post menopausal
    -Surgically sterile
    -Use an accepted contraceptive method such as the contraceptive pill
    • Able to provide written informed consent prior to study participation
    • Able to communicate well with the investigator and comply with the study requirements
    E.4Principal exclusion criteria
    • Lactation, pregnancy or women of childbearing potential not practising an adequate method of contraception, such as oral contraception
    • Hypersensitivity to hydrogel
    • Diabetic patients under inappropriate control (HbA1C more than 10)
    • Participation in a clinical trial within 1 month before start of the trial
    • Patients with grossly oedematous legs, which in the opinion of the recruiting health care professional, are unsuitable for treatment with larval therapy and/or hydrogel
    • Patients on anticoagulants (e.g. warfarin)
    • Recent treatment with topical silver products within one month
    • Recent treatment with oral or topical metronidazole within one month
    • Subject is unable to understand and comply with protocol requirements and instructions and is unlikely to complete the study as planned.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the clinical effectiveness of larval therapy with a standard debridement technique Hydrogel in terms of 75% of clearing of ulcers in patients after (maximum five courses) of larval therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial.
    E.5.2Secondary end point(s)
    • To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) in terms of its effect on time to debridement of leg ulcers.
    • To compare the clinical effectiveness of larval therapy with a standard debridement technique hydrogel in terms of % of clearing, after (maximum five course ) larval therapy.
    • To compare the effect of larval therapy and hydrogel on bacterial load
    • Safety and tolerability of larval therapy
    • Health-related quality of life (including ulcer-related pain) SF-12 and EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial.
    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) 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Hydrogel therapy
    E.8.2.4Number of treatment arms in the trial1
    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 No
    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
    Until 75% of clearing of ulcers in patients after (maximum five courses) of larval therapy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    Reference ulcer will be treated with Tielle® dressing, the control ulcer continue hydrogel therapy, or will be treated with Tielle® dressing depends on the debridement status. Final visit will take place on Day 14 days after removal of last larval therapy, SF-12, EQ-D5 test will be filled. Adverse events, physical examination including vital signs, planimetry of treated ulcers and digital photograph of all ulcers will be performed.
    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 Decision2011-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-26
    P. End of Trial
    P.End of Trial StatusOngoing
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