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    Summary
    EudraCT Number:2007-007940-92
    Sponsor's Protocol Code Number:TR02-107
    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:2008-03-18
    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 number2007-007940-92
    A.3Full title of the trial
    A PLACEBO CONTROLLED, RANDOMIZED, PARALLEL COHORT, SAFETY AND TOLERABILITY STUDY OF TWO DOSE LEVELS OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN PATIENTS WITH BRONCHIECTASIS COMPLICATED BY CHRONIC INFECTION DUE TO PSEUDOMONAS AERUGINOSA
    A.4.1Sponsor's protocol code numberTR02-107
    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 SponsorTransave, 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 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 nameLiposomal Amikacin (Arikace™)
    D.3.4Pharmaceutical form Nebuliser suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMIKACIN SULFATE
    D.3.9.1CAS number 39831555
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) 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 typeSemisynthetic aminoglycoside in a liposomal formulation.
    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 placeboNebuliser suspension
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchiectasis Complicated by Chronic Infection due to Pseudomonas aeruginosa
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of two dose levels of nebulized Arikace™ versus placebo.
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of two dose levels of nebulized Arikace™ versus placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK Sub-Study: Pharmacokinetics (PK) of Arikace™ in urine, blood and sputum will be determined in a subgroup of study subjects who consent to PK evaluation.
    E.3Principal inclusion criteria
    1) Written informed consent obtained from the patient or legal representative prior to the performance of any study related procedures
    2) Male or female study subjects≥ 18 years of age
    3) Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT of the chest
    4) History of chronic infection with P. aeruginosa, defined as:
    At least 1 documented positive culture in the 12 months prior to screening
    AND One or more documented courses of antibiotics for respiratory tract infection in the past 12 months, including either: One course of IV antibiotics OR
    One treatment failure with oral antibiotics requiring additional antibiotic treatment for respiratory tract infection
    5) Confirmation of infection with P. aeruginosa at screening (defined as mucopurulent sputum positive for P. aeruginosa)
    6) SaO2 ≥ 90% at Screening while breathing room air
    7) Ability to comply with study medication use, study visits, and study procedures as judged by the investigator
    8) Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to produce sputum for clinical evaluation
    9) Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
    E.4Principal exclusion criteria
    1) Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening
    2) Subjects with hemoptysis of ≥ 60 ml within 4 weeks prior to screening
    3) Positive pregnancy test or lactation. All women of child bearing potential will be tested
    4) Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration of foreign body, or secondary to lung compression from tumors
    5) History of non-tuberculous mycobacterial and/or Aspergillus infection requiring treatment or treated within 2 years prior to screening
    6) History ofAllergic Bronchopulmonary Aspergillosis requiring systemic steroid treatment or treated within 3 months prior to screening
    7) Pulmonary tuberculosis requiring treatment or treated within two years prior to screening
    8) History of Lung transplantation
    9) More than 3 bronchiectasis exacerbations within 12 months prior to screening
    10) Treatment for bronchiectasis exacerbation within the 4 weeks prior to screening.
    11) Radiographic finding of new pulmonary infiltrate(s) within 2 months prior to screening
    12) Presence of any clinically significant cardiac disease as determined by Investigator: The QTc criteria for Exclusion of subjects is: males QTc> 450 msec (or 0.450 seconds), females QTc> 470 msec (or 0.470 seconds)
    13) Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics) within 4 weeks prior to Study Day 1
    14) Initiation of chronic therapy (e.g., TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics, chronic suppressive antibacterial treatment) within the 28 days prior to Study Day 1
    15) Administration of any investigational drug within 8 weeks prior to screening
    16) Hypersensitivity to aminoglycosides
    17) Evidence of biliary cirrhosis with portal hypertension
    18) AST or ALT ≥ X 3 times the upper limit of normal at Screening
    19) Absolute Neutrophil Count ≤ 1000 performed at Screening
    20) Serum creatinine > X1.8 times normal performed at Screening
    21) History of daily, continuous oxygen supplementation
    22) Smoking tobacco or any substance within 6 months prior to screening, and throughout the study
    23) History of alcohol, medication, or illicit drug abuse within the 1 year prior to screening
    E.5 End points
    E.5.1Primary end point(s)
    • Treatment emergent adverse events up to end of treatment
    • Treatment emergent marked laboratory abnormalities up to 28 days after study medication discontinuation
    • Treatment emergent pulmonary function test (PFT) abnormalities post-dose for acute tolerability assessment
    • Treatment emergent pulmonary function test (PFT) abnormalities up to end of treatment
    • Adverse events leading to permanent discontinuation of study medication
    • Serious adverse events up to 28 days after study medication discontinuation
    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 Yes
    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
    Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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
    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 months
    E.8.9.1In the Member State concerned days56
    E.8.9.2In all countries concerned by the trial days56
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    After completion of this study, subjects will be followed up for an additional 6 months via phone contacts and records review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol).
    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 Decision2008-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-30
    P. End of Trial
    P.End of Trial StatusCompleted
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