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    Summary
    EudraCT Number:2013-003227-11
    Sponsor's Protocol Code Number:DUR001-106
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-14
    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 ConcernedEstonia - SAM
    A.2EudraCT number2013-003227-11
    A.3Full title of the trial
    PHASE 1, OPEN LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF DALBAVANCIN IN HOSPITALIZED CHILDREN AGED 3 MONTHS TO 11 YEARS RECEIVING STANDARD INTRAVENOUS ANTI-INFECTIVE TREATMENT FOR BACTERIAL INFECTIONS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the pharmacokinetics, safety and tolerability of a single dose of intravenous dalbavancin in children hospitalized due to known or suspected bacterial infection.
    A.4.1Sponsor's protocol code numberDUR001-106
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01946568
    A.5.4Other Identifiers
    Name:IND NumberNumber:60,613
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/223/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDurata Therapeutics International B.V.
    B.1.3.4CountryNetherlands
    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 supportDurata Therapeutics International B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDurata Therapeutics International B.V.
    B.5.2Functional name of contact pointExecutive Director Clinical and Med
    B.5.3 Address:
    B.5.3.1Street Address322 E. Main St. 3rd Floor
    B.5.3.2Town/ cityBranford Ct
    B.5.3.3Post code06405
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1203-871-4613
    B.5.5Fax number+1203-315-0115
    B.5.6E-mailjbaldassarre@duratatx.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 Dalvance
    D.2.1.1.2Name of the Marketing Authorisation holderDurata Therapeutics International B.V.
    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 nameDalbavancin
    D.3.2Product code DUR001
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    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 INNDalbavancin
    D.3.9.1CAS number 171500-79-1
    D.3.9.2Current sponsor codeDUR001
    D.3.9.3Other descriptive nameDALBAVANCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB130539
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Bacterial Infection in hospitalized children
    E.1.1.1Medical condition in easily understood language
    Bacterial Infection in children
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10004044
    E.1.2Term Bacterial infection NOS
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10004043
    E.1.2Term Bacterial infection in conditions classified elsewhere and of unspecified site
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetics (PK) of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of single dose administration of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive),
    - To enable dose estimation for patients less than 3 months of age,
    - To enable dose selection for a pediatric phase 3 study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalized male and female patients in 3 age cohorts from 3 months to 11 years of age (inclusive) who will be receiving at least 24 hours of appropriate non-investigational intravenous anti-infective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled.
    2. Each patient’s parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. If required by the local IRB, assent of the patients in the two older cohorts will be obtained.
    3. Patients and if required by local/site regulations their parent(s)/legal guardian(s) must be willing and able, if discharged from the hospital, to return to the hospital or a designated clinic for scheduled visits, treatment, laboratory tests and other out-patient procedures as required by the protocol.
    4. Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.
    5. Patients must have an audiologic assessment within 7 days prior to the study drug infusion consisting of symmetric hearing testing utilizing evoked otoacoustic emissions and acoustic immittance measures.
    E.4Principal exclusion criteria
    1.Treatment with an investigational drug within 30 days preceding the first dose of study medication.
    2.Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication.
    3.Patients with any clinically significant abnormality following review of screening laboratory data other than that associated with their underlying disease. Such abnormalities include aminotransferases (AST, ALT) >5 x ULN; total bilirubin and/or alkaline phosphatase >2 x ULN.
    4.Albumin < half lower limit of normal.
    5.Patients who are less than one year of age and were born with gestational age of less than 32 weeks.
    6.Patients diagnosed with cystic fibrosis.
    7.Positive urine (or serum) pregnancy test at screening (post menarchal females only) or after admission (prior to dosing).
    8.Patients known to have hypersensitivity to glycopeptides.
    9.Patients with calculated creatinine clearance <30 ml/min. Creatinine clearance will be calculated using the Schwartz method:

    Children < 1 year: CLCr = (ml/min/1.73m2)= [length (cm) x 0.45]/Scr
    Children ≥ 1 year: CLCr = (ml/min/1.73m2)= [length (cm) x 0.55]/Scr

    10.Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior or hormonal contraception for at least 3 months prior to the dose of study medication until the end of the study and completion of follow-up procedures (female patients to have pregnancy testing are those who are at least 10 years old with menarche and/ or thelarche (beginning of breast development)).
    11.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1: 0.5 hours (within thirty minutes after the end of the infusion).
    ◦ Post -start-of-infusion: 4 hours (± 2 hours) and 12 hours (± 2 hours)
     Day 2: 24 hours (Day 2 ± 4 hours) post-start-of-infusion on Day 1.
     Day 7: 144 hours (Day 7 ± 2 days) post -start-of-infusion on Day 1.
     Day 28: 648 hours (Day 28  4 days) post-start-of-infusion on Day 1.
    E.5.2Secondary end point(s)
    Safety and tolerability of single dose administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 2, 7, 28
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration in children in these age groups
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    3 cohorts: Enrollment in Cohort 3 initiated after completion of a safety assessment in Cohorts 1&2
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    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 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
    Estonia
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 36
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    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 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
    Hospitalized children at the age of 3 months to 11 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 36
    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
    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 Decision2014-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-16
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