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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-005450-19
    Sponsor's Protocol Code Number:D5180C00002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2014-005450-19
    A.3Full title of the trial
    A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 in Adolescents with Mild to Moderate Asthma
    Otwarte badanie fazy pierwszej w celu oceny farmakokinetyki MEDI9929 u nastolatków z astmą w stopniu łagodnym do umiarkowanego.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Investigate the Effects of MEDI9929, a Drug Under Investigation, in Adolescents with Mild to Moderate Asthma
    Badanie kliniczne w celu oceny efektów MEDI9929, leku badanego, u nastolatków z astmą w stopniu łagodnym do umiarkowanego.
    A.4.1Sponsor's protocol code numberD5180C00002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/316/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)
    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 supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC)
    B.5.2Functional name of contact pointJacki Sorrells
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number001301398-6493
    B.5.5Fax number001301398-8269
    B.5.6E-mailsorrellsj@medimmune.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 nameMEDI9929/AMG157
    D.3.2Product code MEDI9929
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpending
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929/AMG157
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Asthma
    Astma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Astma
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 in adolescent subjects with mild to moderate asthma.
    Ocena profilu PK MEDI9929 podanego podskórnie (SC) w pojedynczej dawce 140 mg u nastolatków z astmą w stopniu łagodnym do umiarkowanego
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of MEDI9929
    2. To evaluate the immunogenicity of MEDI9929
    1. Ocena bezpieczeństwa i tolerancji MEDI9929
    2. Ocena immunogenności MEDI9929
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 12 to 17 years (inclusive) at both screening and Day 1
    - Physician diagnosed asthma for a minimum of 6 months prior to screening.
    - Weight ≥ 30 kg at both screening and Day 1
    - Body mass index for age at both screening and Day 1 that is between 5th and 95th percentile (Centers for Disease Control Growth Charts).
    - Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions through Day 85, and as a precaution, for an additional 45 days; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
    - Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85, and as a precaution, for an additional 45 days
    - Pacjent w wieku 12-17 lat (włącznie) w dniu skriningu i w Dniu 1.
    - Zdiagnozowana przez lekarza astma minimum 6 miesięcy przed skriningiem.
    - Waga ≥ 30 kg w dzień skriningu i w Dniu 1.
    - Wskaźnik masy ciała (BMI) w stosunku do wieku, w dniu skriningu i w Dniu 1 pomiędzy 5-tym i 95-tym percentylem (Centers for Disease Control Growth Charts).
    - Kobiety mogące zajść w ciąże, będące aktywne seksualnie z niewysterylizowanym partnerem płci męskiej, muszą używać wysoce skutecznych metod antykoncepcyjnych od dnia skriningu oraz muszą zgodzić się na kontynuowanie stosowania tych środków ostrożności do 85 Dnia badania, oraz, jako dodatkowy środek ostrożności, przez kolejnych 45 dni; zaprzestanie kontroli urodzeń po tym czasie powinno zostać przedyskutowane z odpowiedzialnym za to lekarzem. Okresowa wstrzemięźliwość, metoda kalendarzykowa oraz stosunek przerywany nie są akceptowalnymi metodami kontroli urodzeń.
    - Niewysterylizowani mężczyźni, którzy są aktywni seksualnie z partnerką płci żeńskiej mogącą zajść w ciążę, muszą stosować wysoce skuteczną metodę antykoncepcyjną od Dnia 1 do Dnia 85, oraz, jako dodatkowy środek ostrożności, przez kolejnych 45 dni
    E.4Principal exclusion criteria
    - Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
    - History of intubation for the management of a deterioration in asthma.
    - History of systemic corticosteroid use for the maintenance treatment of asthma within 3 months prior to screening.
    - Pregnant or breastfeeding females.
    - Current tobacco smoking or cessation of smoking for ≤ 6months prior to screening.
    - Any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A.
    - Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll
    - A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject’s verbal report
    - History of cancer
    - Any active medical condition other than asthma, that in the opinion of the investigator and/or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study (subjects with atopic skin conditions and allergic rhinitis are permitted)
    - Pracownicy ośrodka prowadzącego badanie kliniczne lub jakiekolwiek inne osoby zaangażowane w prowadzenia badania lub najbliżsi członkowie rodzin tych osób.
    - Historia intubacji z powodu zaostrzenia astmy.
    - Historia stosowania kortykosteroidu systemowego w celu leczenia zachowawczego astmy w ciągu 3 miesięcy przed skriningiem.
    - Kobiety w ciąży lub karmiące piersią.
    - Palenie tytoniu lub zaprzestanie palenia tytoniu w ciągu ≤ 6 miesięcy przed skriningiem.
    - Historia jakichkolwiek znanych zaburzeń pierwotnych niedoborów immunologicznych, za wyjątkiem bezobjawowego selektywnego niedoboru immunoglobuliny A.
    - Pozytywny antygen powierzchniowy wirusa zapalenia wątroby typu B lub przeciwciała przeciwko wirusowi zapalenia wątroby typu C w serologii. Uczestnicy z historią szczepienia przeciwko wirusowemu zapaleniu wątroby typu B, ale bez historii choroby są dopuszczeni do włączenia do badania.
    - Pozytywny wynik badania na obecność wirusa niedoboru immunologicznego człowieka (HIV) podczas skriningu lub przyjmowanie przez uczestnika leków antyretrowirusowych, ustalone na podstawie medycznej historii i/lub ustnie zgłoszone przez uczestnika.
    - Historia występowania nowotworu.
    - Jakikolwiek czynny stan chorobowy inny niż astma, który w opinii badacza i/lub monitora medycznego może zagrażać bezpieczeństwu uczestnika badania lub wpływać na ocenę badanego produktu lub ograniczać zdolność uczestnika do brania udziału w badaniu (pacjenci z atopowym zapaleniem skóry i alergicznym nieżytem nosa mogą być dopuszczeni do badania).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is MEDI9929 PK parameters: area under the time-concentration curve from zero to infinity and to last observation (AUC(0-infinity) and AUC(0-t), respectively); dose-normalized AUC(0-infinity) (AUC(0 infinity)/D); maximum observed serum concentration (Cmax); dose-normalized Cmax (Cmax/D); time to reach C max ( tmax); terminal elimination half-life ( t1/2z); apparent clearance (CL/F); and apparent steady-state volume of distribution (Vss/F).
    Pierwszorzędowym punktem końcowym tego badania są parametry PK MEDI9929: pole pod krzywą zależności stężenia od czasu od zera do nieskończoności oraz do ostatniej obserwacji (AUC(0-nieskończoności)) oraz AUC(0-t), odpowiednio); dawka znormalizowana AUC(0-nieskończoności) (AUC(0-nieskończoności)/D); maksymalne zaobserwowane stężenie w surowicy (Cmax); Cmax dawki znormalizowanej (Cmax/D); czas do osiągnięcia Cmax (tmax); okres półtrwania w końcowej fazie eliminacji (t1/2z); klirens pozorny (CL/F); oraz pozorna objętość dystrybucji w stanie stacjonarnym (Vss/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be 11 PK assessments from administration of investigational product up to, and including, Day 85.
    Będzie 11 ocen PK od podania leku badanego, aż do Dnia 85 włącznie.
    E.5.2Secondary end point(s)
    1. Safety parameters: treatment-emergent adverse events, vital signs, physical examination, laboratory
    measurements, and electrocardiogram (ECG)
    2. Immunogenicity: anti-drug antibodies (ADAs) to MEDI9929
    1. Parametry bezpieczeństwa: zdarzenia niepożądane wynikające z leczenia, parametry życiowe, badanie fizykalne, pomiary laboratoryjne oraz elektrokardiogram (EKG)
    2. Immunogenność: przeciwciała (ADA) skierowane przeciw MEDI9929
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint will be measured up to Day 85
    Drugorzędowe punkty końcowe będą mierzone do Dnia 85
    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
    First administration to adolescent subjects
    Pierwsze podanie u nastoletnich pacjentów
    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 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 concerned6
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    ostatnia wizyta ostatniego pacjenta
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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
    Informed consent for study participation will be obtained and documented from the legal representatives for all adolescence subjects
    Świadoma zgoda na udział w badaniu będzie uzyskana i udokumentowana od opiekunów prawnych wszystkich nastoletnich uczestników badania
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    Brak
    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 Decision2015-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-17
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