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    Summary
    EudraCT Number:2006-005003-33
    Sponsor's Protocol Code Number:WSA-CS-003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-005003-33
    A.3Full title of the trial
    Open label study of isavuconazole in the treatment of patients with aspergillosis and renal impairment or of patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
    A.4.1Sponsor's protocol code numberWSA-CS-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00634049
    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 Global Pharma 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
    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
    B.5.2Functional name of contact pointClinical Trial Support
    B.5.3 Address:
    B.5.3.1Street Address1 Astellas Way
    B.5.3.2Town/ cityNorthbrook, IL
    B.5.3.3Post code60062
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials.info@us.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 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 nameisavuconazole
    D.3.2Product code BAL4815
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsavuconcazonium sulfate
    D.3.9.2Current sponsor codeBAL4815
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 nameisavuconazole
    D.3.2Product code BAL4815
    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 INNIsavuconazonium sulfate
    D.3.9.2Current sponsor codeBAL4815
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Invasive fungal disease caused by Aspergillus species and Candida strains in patients with renal impairment as well as disease caused by rare moulds, yeats or dimorphic fungi.
    E.1.1.1Medical condition in easily understood language
    Aspergillosis / Invasive Fungal Infections
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10003486
    E.1.2Term Aspergillus infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049160
    E.1.2Term Candidaemia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the safety and efficacy of isavuconazole in the treatment of invasive aspergillosis in patients with renal impairment or in patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.
    E.2.2Secondary objectives of the trial
    To determine clinical and mycological response rate by pathogen.
    To evaluate the survival status at Day 42, 84, 120 and 180.
    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 selected sites with appropriate facilities and equipment the PK of BAL4815 and cleavage product BAL8728 will be evaluated in patients treated with isavuconazole. Seven plasma samples including samples from at least 10 patients aged < 42 years and 10 patients aged > 65 years will be collected on Day 7 or 14 for PK profiling.
    If PK data permits within the sub-study, an assessment of the route of administration will be assessed.
    Additionally, time above the minimum inhibitory concentration (MIC) should also be captured.
    E.3Principal inclusion criteria
    1. Patients and/or legal authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent and HIPAA Authorization for US sites, or equivalent privacy language as per national regulations or Patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent, and
    HIPAA Authorization for US sites, or equivalent privacy language as per national regulations, witnessed in writing by an independent person.
    2. Ability and willingness to comply with the protocol.
    3. Male and female patients aged ≥ 18 years, at the time of signing the informed consent form.
    4. Female patients must be non-lactating and at no risk for pregnancy
    5. Patients who fall into one of the following 5 subgroups:
    a) Patients with proven, probable or possible invasive aspergillosis who have renal impairment ( including dialysis) OR
    b) Patients meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi, whether renally impaired or not (including dialysis), who require primary therapy for their IFD at the time of enrollment as defined in the body of the protocol.
    OR
    c) Patients who have proven or probable zygomycosis, whether they are renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.
    OR
    d) Patients meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi, whether renally impaired or not (including dialysis), who are refractory to current treatment defined as:
    -clear documentation of progression of disease
    -failure to improve clinically despite currently receiving at least 7 days of standard antifungal regimen
    OR
    e) Patients meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi, whether renally impaired or not (including dialysis), who are intolerant to current treatment, for example:
    -doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours
    or
    -serum creatinine > 2.0 mg/ml and current treatment with polyene or IV voriconazole
    or
    -other significant drug-related adverse reaction(s) to the current antifungal agent, resulting in discontinuation of the treatment, e.g. persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction
    or
    -documented inability to achieve adequate blood levels of posaconazole, voriconazole or itraconazole.
    E.4Principal exclusion criteria
    1. Women who are pregnant or breastfeeding.
    2. Known history of allergy, hypersensitivity, or any serious reaction to the azole class of antifungals or to any component of the study medication.
    3. Patients at high risk for QT prolongation
    4. Patients with evidence of hepatic dysfunction with any of the following abnormalities at the time of enrollment:
     Total bilirubin > 3 x upper limit of normal (ULN) OR
     Alanine transaminase (ALT) or aspartate transaminase (AST) > 5 x ULN OR
     Patients with known cirrhosis or chronic hepatic failure
    5. Concomitant use of astemizole, cisapride, rifampin/rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, ritonavir, efavirenz, carbamazepine, pimozide, quinidine, neostigmine,
    terfenadine, ketoconazole, valproic acid or St. John’s Wort in the 5 days prior to first administration of study medication.
    6. Patients with either chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis (ABPA).
    7. Microbiological findings (e.g. virological) or other potential conditions that are temporally related and suggest a different etiology for the clinical features in the absence of evidence of
    systemic fungal infection.
    8. Advanced human immunodeficiency virus (HIV) infection with CD4 count < 50 or uncontrolled acquired immunodeficiency syndrome-defining condition.
    9. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy
    10. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study.
    11. Patients previously enrolled in a phase III study with ISA.
    12. Treatment with any investigational drug in any clinical trial 30 days prior to the first administration of study medication except open label protocols.
    13. Patients who are unlikely to survive 30 days.
    14. Patients with a body weight < 40 kg.
    15. Patients who need primary therapy for invasive aspergillosis who have been administered more than 4 cumulative days of itraconazole, voriconazole, or posaconazole, for any reason,
    within the 7 days prior to the first administration of study medication.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the overall outcome of treatment (clinical, mycological and radiological response) evaluated by DRC at Day 42 by subgroup (e.g. type of pathogen).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42
    E.5.2Secondary end point(s)
     Overall outcome of treatment evaluated by Investigator at Day 42 by sub-group
     Overall outcome at EOT and Day 84, assessed by DRC and Investigator by sub-group
     Clinical response at Days 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group
     Mycological response at Day 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group
     Survival rate at Day 42, Day 84, Day 120 and Day 180
    E.5.2.1Timepoint(s) of evaluation of this end point
     Overall outcome of treatment evaluated by Investigator at Day 42 by sub-group
     Overall outcome at EOT and Day 84, assessed by DRC and Investigator by sub-group
     Clinical response at Days 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group
     Mycological response at Day 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group
     Survival rate at Day 42, Day 84, Day 120 and Day 180
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 No
    E.8.1.1Randomised No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Egypt
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Lebanon
    Mexico
    Poland
    Russian Federation
    South Africa
    Taiwan
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 2007-11-27. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients unable to write and / or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person.
    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 120
    F.4.2.2In the whole clinical trial 360
    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)
    None
    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 Decision2007-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-05
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