Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
16. november 2016 opdateret af: Novartis Pharmaceuticals
A 24 Week, Open Label, Multi-center Evaluation of Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment
The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level).
The investigators will also assess how well PK/PD data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults and children, and assess efficacy and safety data in Japanese pediatric patients which will fulfill the Japanese health authority requirement for approval.
Data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in Japan.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chiba, Japan, 266-0007
- Novartis Investigative Site
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Fukuoka, Japan, 811-1394
- Novartis Investigative Site
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Gifu, Japan, 501-1194
- Novartis Investigative Site
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Osaka, Japan, 530-0012
- Novartis Investigative Site
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Aichi
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Ohbu, Aichi, Japan, 474-0031
- Novartis Investigative Site
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Kanagawa
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Sagamihara, Kanagawa, Japan, 228-8522
- Novartis Investigative Site
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Yokohama, Kanagawa, Japan, 245-8575
- Novartis Investigative Site
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Yokohama, Kanagawa, Japan, 232-8555
- Novartis Investigative Site
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Mie
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Tsu, Mie, Japan, 514-0125
- Novartis Investigative Site
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Nara
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Tenri, Nara, Japan, 632-8552
- Novartis Investigative Site
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Osaka
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Habikino, Osaka, Japan, 583-8588
- Novartis Investigative Site
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Tochigi
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Shimotsuka-gun, Tochigi, Japan, 321-0293
- Novartis Investigative Site
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Tokyo
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Fuchu, Tokyo, Japan, 183-8561
- Novartis Investigative Site
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Komae, Tokyo, Japan, 201-8601
- Novartis Investigative Site
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Setagaya-ku, Tokyo, Japan, 157-8535
- Novartis Investigative Site
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Setagaya-ku, Tokyo, Japan, 158-0097
- Novartis Investigative Site
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Sumida-ku, Tokyo, Japan, 130-8587
- Novartis Investigative Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 15 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Body weight and serum total IgE level within the dosing table range; body weight of 20 to 150 kg and serum total IgE levels of 30 to 1300 IU/mL
- Receiving asthma long-term control medications of high dose ICS (>200 µg/day FP or equivalent) and two or more controller medications out of LTRA, theophylline, sodium cromoglycate, LABA, or OCSs 12 weeks prior to the run-in period. These medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
- Having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ICS dose for at least 3 days and/or systemic (oral or IV) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
- Demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary which meet any of the following:
Asthma symptoms every day; Night-time symptoms in ≥2 out of the last 14 days (missing data to be treated as a day with no symptoms); Limitation of daily activities in ≥2 out of the last 14 days (missing data to be treated as a day with no limitations)
Exclusion Criteria:
- With a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
- With positive skin reaction to the study drug at the run-in period
- With known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
- With platelet level ≤ 100,000/µL (100 x 109/L) at the run-in period
- Who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
- Who are taking systemic (oral or IV) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic OCSs use for asthma are allowed)
Other protocol-defined inclusion/exclusion criteria may apply
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Omalizumab
Omalizumab treatment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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To examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients reaches under 25 ng/mL (target level).
Tidsramme: 24 weeks
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24 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To assess PK/PD data by modeling & simulation
Tidsramme: 24 weeks
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24 weeks
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To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score.
Tidsramme: 24 weeks
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24 weeks
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To assess the safety of omalizumab
Tidsramme: 24 weeks
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24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først indsendt
30. juni 2010
Først indsendt, der opfyldte QC-kriterier
1. juli 2010
Først opslået (Skøn)
2. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIGE025B1301
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .