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    Summary
    EudraCT Number:2012-000780-24
    Sponsor's Protocol Code Number:9463-CL-2303
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-30
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-000780-24
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to Compare the Efficacy and Safety of Micafungin versus Amphotericin B Deoxycholate to Treat Neonatal Candidiasis
    A.3.2Name or abbreviated title of the trial where available
    MAGIC-2
    A.4.1Sponsor's protocol code number9463-CL-2303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00815516
    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 SponsorAstellas Pharma Global Development, Inc.
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc.
    B.5.2Functional name of contact pointAstellas Neonatal Fungal Study
    B.5.3 Address:
    B.5.3.1Street Address1Astellas Way
    B.5.3.2Town/ cityNorthbrook
    B.5.3.3Post codeIL 60062
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12242056350
    B.5.6E-mailAstellasNeonatalFungalStudy@astellas.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 Yes
    D.2.1.1.1Trade name Mycamine 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namemicafungin sodium for injection
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 208538-73-2
    D.3.9.3Other descriptive nameMICAFUNGIN SODIUM
    D.3.9.4EV Substance CodeSUB20666
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Amphotericin B for Injection USP
    D.2.1.1.2Name of the Marketing Authorisation holderX-Gen Pharmaceuticals, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAmphotericin B deoxycholate
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmphotericin B
    D.3.9.1CAS number 1397-89-3
    D.3.9.3Other descriptive nameCAB
    D.3.9.4EV Substance CodeSUB05486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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) 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.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
    Neonatal Candidiasis
    E.1.1.1Medical condition in easily understood language
    Fungal infection in the neonate
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 efficacy and safety of Micafungin in comparison to amphotericin B deoxycholate (CAB) in the treatment of proven neonatal candidiasis

    E.2.2Secondary objectives of the trial
    To further evaluate the pharmacokinetics of micafungin as well as CAB in this patient population
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In the United States of America, billing information and data on length of stay will be obtained from each infant’s hospitalization during the study for a health economic assessment for those infants where consent is specifically obtained.
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Infant greater than 48 hours of life up to DOL 120 at the time of culture acquisition.
    3. Diagnosis of invasive candidiasis by one of the following (see Appendix 1 for Site-Specific Diagnostic Criteria):
    a. Proven Candidemia: One positive blood culture collected within 4 days prior to the first dose of study drug.
    b. Proven Candiduria: One positive urine fungal culture obtained within 4 days prior to the first dose of study drug by I/O catheterization or suprapubic aspiration. A fungal culture obtained from an indwelling catheter is acceptable only if the culture was obtained at the time the catheter was placed. Positive fungal culture must show greater than or equal to 1000 CFU/mL in a single urine culture collected via I/O catheterization or greater than or equal to 100 CFU/mL in a single urine culture collected via suprapubic aspiration.
    c. Proven Candida Meningitis: The presence of Candida species in CSF culture obtained within +/- 4 days from the first dose of study drug.
    d. Candida – Other focus:
    i. Positive tissue biopsy or positive culture from a normally sterile body fluid obtained within 4 days prior to the first dose of study drug, or
    ii. Positive culture for Candida (or yeast) that was taken from a new drain either at the time of drain placement or within 24 hours after placement from a normally sterile site. The drain must have been placed within 7 days prior to the first dose of study drug. NB: Culture results to confirm Candida species may be pending at the time of enrollment if the following criteria are met:
    - For candidemia, staining/microscopy of the blood culture sample reveals preliminary evidence of yeast.
    - For invasive candidiasis other than candidemia, histology/cytology reveals findings consistent with yeast.
    NB: All Candida organisms must be speciated.
    4. Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
    5. Subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment.
    NB: Waivers to the inclusion criteria will NOT be allowed.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product.
    2. Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug for treatment of the current Candida infection. Cumulative doses must not exceed 2 mg/kg of CAB. For systemic antifungal therapy not specifically stated here,
    infants with more than 2 therapeutic daily doses within the 48 hours prior to the first dose of study drug will not be eligible.
    3. Infant who has a breakthrough systemic fungal infection while receiving an amphotericin B product or an echinocandin as prophylaxis.
    NB: Infants with a breakthrough fungal infection while receiving azole prophylaxis will be eligible for enrollment.
    4. Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis, including recurrence of the same Candida infection within 2 weeks of completing systemic antifungal therapy.
    5. Infant with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
    6. Infant previously enrolled in this study.
    7. Infant who is co-infected with a non-Candida fungal organism.
    8. Infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum.
    NB: Waivers to the exclusion criteria will NOT be allowed.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is fungal free survival at one week following the last dose of study drug.
    Fungal free survival is defined as alive at one week following the last dose of study drug and eradication (fungal free) with no requirement for alternative systemic antifungal therapy for continued treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One week following the last dose of study drug
    E.5.2Secondary end point(s)
    - Time to mycological clearance of invasive candidiasis.
    - Fungal free survival in infants with end-organ dissemination at end of
    study drug therapy and one week after last dose of study drug.
    - Overall incidence of emergent and recurrent fungal infections through the end of study.
    - Time to positive clinical response (complete or partial).
    - Clinical response (complete, partial, stabilization, progression) at the end of study drug therapy and one week after last dose of study drug.
    - Mycological response at end of study drug therapy and one week after
    last dose of study drug.
    - Status of follow-up imaging and exams (improved, stable, worse) for
    infants with end-organ assessments.
    - Model parameters such as clearance and volume of distribution.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of study drug therapy and/or one week after last dose of study drug.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Greece
    Croatia
    Romania
    Argentina
    Brazil
    Chile
    Colombia
    Ecuador
    Hungary
    Lebanon
    Spain
    Thailand
    Israel
    Mexico
    Peru
    Philippines
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    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
    LVLS

    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.1.1Number of subjects for this age range: 225
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 75
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 75
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 75
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Neonates
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 225
    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)
    Standard of Care in the country. An End of Study (post-treatment) Visit will occur 30 days, ± 3 days, after the last dose of study 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 Decision2013-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-15
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