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    Summary
    EudraCT Number:2010-023426-20
    Sponsor's Protocol Code Number:AUGUST-2
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023426-20
    A.3Full title of the trial
    Low dose Urokinase therapy in patients with diabetic foot syndrome, critical limb ischemia as well as rest ischemia or missing of option revascularisation in comparison to the standard therapy - randomized, open, controlled phase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with Urokinase in patients with diabetic foot, non-healing wounds and pain in comparison to the standard therapy.
    A.3.2Name or abbreviated title of the trial where available
    AUGUST-2
    A.4.1Sponsor's protocol code numberAUGUST-2
    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 SponsorGWT-TUD GmbH
    B.1.3.4CountryGermany
    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 supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGWT-TUD GmbH
    B.5.2Functional name of contact pointStudienambulanz
    B.5.3 Address:
    B.5.3.1Street AddressFriedrichstrasse 41
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01067
    B.5.3.4CountryGermany
    B.5.4Telephone number00493514804556
    B.5.5Fax number00493517979031
    B.5.6E-mailaugust@gwtonline-fb.de
    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 Urokinase HS medac
    D.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameUrokinase HS medac
    D.3.2Product code Urokinase HS medac
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUrokinase
    D.3.9.1CAS number 9039-53-6
    D.3.9.2Current sponsor codeUrokinase
    D.3.9.3Other descriptive nameUROKINASE
    D.3.9.4EV Substance CodeSUB05055MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman urokinase (IUPAC)
    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
    Diabetic foot syndrome with critical limb ischemia
    E.1.1.1Medical condition in easily understood language
    Non-healing wounds and loss of blood supply in the limbs of diabetic patients
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    Lengthening of survival free of major amputation by a low dose therapy with Urokinase as a daily short infusion with 10 to 21 doses over max. 30 days within the scope of a randomized, controlled study
    E.2.2Secondary objectives of the trial
    • lengthening of survival free of major amputation one year after randomization
    • major amputation
    • overall mortality after 12 months
    • minor amputation
    • number of revision surgeries with minor amputations
    • healing of the aim lesions (DFS)
    • new lesions in the affected leg (index leg)
    • new lesions in a previously not affected leg (not index leg)
    • efficacy with dialysis patients

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients ≥ 18 years with diabetes and angiopathic or angioneuropathic diabetic foot syndrome with critical limb ischemia (at least Wagner-Armstrong stage 2C)

    Additional inclusion criteria:
    • No revascularization possible or rest ischemia after revascularization (ALP with
    collateral curve, to post-stenosis curve or dumb curve or ABI <0.9 or Doppler
    trace with character of stenosis or missing, TcPO2 <30 mmHg)

    • Persistent ulcerations in spite of anti-biosis, blood glucose adjustment and
    wound debridement

    • Expected further in-patient stay of at least 3 weeks (antibiotic therapy as well as
    decompression)

    • Fibrinogen ≥ 4.0 g/ll

    E.4Principal exclusion criteria
    • prospective life expectancy <1 year
    • former major amputation
    • treatment strategy major amputation after interdisciplinary treatment team
    • pre-treatment of the current episode of the diabetic foot syndrome with Urokinase (permitted in connection with the revascularization with the distance to the randomization then being minimally 7 days)

    • mechanical heart valve replacement

    • cerebral event with CT-alteration within the last 3 months

    • non-cured, proliferative retinopathy

    • uncontrollable hypertension (syst. RR > 80 mmHg, diast. RR >100 mmHg

    • hemorrhagic diathesis (spontaneous-Quick <50%, spontaneous-PTT > 40 s,
    platelets <100 Gpt/l)

    • gastrointestinal bleeding or ulcers during the last 4 weeks

    • reverse bypass operation

    • existence of other contra-indications for a Urokinase therapy according to the
    current specialized information

    • concurrent participation in another clinical study

    • lacking compliance
    E.5 End points
    E.5.1Primary end point(s)
    Lengthening of the survival free of major amputation in the Urokinase group in contrast to the group treated with standard therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after randomization
    E.5.2Secondary end point(s)
    • lengthening of survival free of major amputation one year after randomization
    • major amputation
    • overall mortality after 12 months
    • minor amputation
    • number of revision surgeries with minor amputations
    • healing of the aim lesions (DFS)
    • new lesions in the affected leg (index leg)
    • new lesions in a previously not affected leg (not index leg)
    • efficacy with dialysis patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after randomization
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    untreated control group
    E.8.2.4Number of treatment arms in the trial2
    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 concerned20
    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 Yes
    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
    Data base closure
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 months0
    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) Yes
    F.1.3.1Number of subjects for this age range: 161
    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 2010-12-03. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state211
    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)
    Normal subsequent treatment
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-11-22
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