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    Summary
    EudraCT Number:2015-001225-16
    Sponsor's Protocol Code Number:DORIPED1001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-24
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-001225-16
    A.3Full title of the trial
    An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic Fibrosis
    A.4.1Sponsor's protocol code numberDORIPED1001
    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 SponsorJohnson & Johnson Pharmaceutical Research & Development L.L.C
    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 supportJohnson & Johnson Pharmaceutical Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJohnson & Johnson Pharmaceutical Research & Development
    B.5.2Functional name of contact pointClinical Registry Group-JB BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 DORIBAX
    D.2.1.1.2Name of the Marketing Authorisation holderShionogi 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 nameDORIBAX
    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 INNDORIPENEM HYDRATE
    D.3.9.1CAS number 364622-82-2
    D.3.9.3Other descriptive nameDORIPENEM HYDRATE
    D.3.9.4EV Substance CodeSUB26847
    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
    Cystic fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis, disorder of the lungs
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacokinetics of doripenem after a single 30 mg/kg doripenem 4-hour i.v. infusion administered to pediatric subjects 6 to 17 years of age, inclusive, with cystic fibrosis (CF). Safety and tolerability will also be assessed.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Boy or girl between 6 years of age and 17 years of age, inclusive, with a confirmed diagnosis of CF (documented sweat chloride ≥60 mEq/L by quantitative pilocarpine iontophoresis test [QPIT] and/or homozygosity for ΔF508 genetic mutation (or heterozygosity for 2 known mutations)
    - Subjects must be medically stable, without acute decline in physical condition in the investigator's judgment.
    - A parent or the subject's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) and capable of providing it, as described in Section 11.2.3, Informed Consent/Assent and as approved by institutional-specific guidelines
    - Suspected or diagnosed with an infection, colonization, or prophylaxis for which the subject is receiving antibiotic therapy
    - Menarchal girls must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, or abstinence for the duration of the study) before entry and throughout the study
    - Menarchal girls, must have a negative urine pregnancy test at screening
    - If a boy, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., abstinence, vasectomy, double-barrier, partner using effective contraception)
    - Be a non-smoker
    E.4Principal exclusion criteria
    - History of colonization with B. cepacia within the past 6 months
    - Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator. If the results of the chemistry, hematology, or urinalysis tests are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
    - Clinically significant abnormal physical examination or vital signs at screening as deemed appropriate by the investigator. If the results of the physical examination or vital signs, are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
    - History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other β-lactam antibiotics
    - Known allergy to heparin or history of heparin induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used
    - Subjects concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration
    - Subjects concomitantly treated with probenecid or VPA (refer to Section 5.5, Concomitant Therapy)
    - Had substantial loss of blood (more than 10% of total blood volume) within 3 months before the administration of study drug
    - Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug’s half-life, whichever is longer, before the administration of the study drug is scheduled
    - If a menarchal girl, pregnant, breast-feeding or planning to become pregnant during the study
    - Preplanned surgery or procedures that would interfere with the conduct of the study
    - Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    - History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or subject’s verbal report
    E.5 End points
    E.5.1Primary end point(s)
    Assess the pharmacokinetics, safety and tolerability of a single 30mg/kg dose of doripenem in pediatric subjects 6 to 17 years of age, with Cystic Fibrosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 10 days
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 No
    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
    Evaluate pharmacokinetics
    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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months10
    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: 22
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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
    Children 6-17 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 22
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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