Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)
2018年1月18日 更新者：GlaxoSmithKline
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma
The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications.
The study will look at different doses of mepolizumab in comparison to a placebo.
調査の概要
詳細な説明
A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma.
Efficacy will be measured by the frequency of asthma exacerbations.
In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed.
Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs.
Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.
研究の種類
介入
入学 (実際)
621
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Long Beach、California、アメリカ、90808
- GSK Investigational Site
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Los Angeles、California、アメリカ、90095
- GSK Investigational Site
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Riverside、California、アメリカ、92506
- GSK Investigational Site
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San Diego、California、アメリカ、92103-8415
- GSK Investigational Site
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Colorado
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Denver、Colorado、アメリカ、80206
- GSK Investigational Site
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- GSK Investigational Site
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Georgia
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Albany、Georgia、アメリカ、31707
- GSK Investigational Site
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Columbus、Georgia、アメリカ、31904
- GSK Investigational Site
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Kentucky
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Lexington、Kentucky、アメリカ、40508
- GSK Investigational Site
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- GSK Investigational Site
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27103
- GSK Investigational Site
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Ohio
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Canton、Ohio、アメリカ、44718
- GSK Investigational Site
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Cleveland、Ohio、アメリカ、44195
- GSK Investigational Site
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73103
- GSK Investigational Site
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- GSK Investigational Site
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Pittsburgh、Pennsylvania、アメリカ、PA 15213
- GSK Investigational Site
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South Carolina
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Charleston、South Carolina、アメリカ、29406
- GSK Investigational Site
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- GSK Investigational Site
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Texas
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Boerne、Texas、アメリカ、78006
- GSK Investigational Site
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Houston、Texas、アメリカ、77054
- GSK Investigational Site
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- GSK Investigational Site
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Buenos Aires、アルゼンチン、1425
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires、アルゼンチン、C1426ABP
- GSK Investigational Site
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Mendoza、アルゼンチン、M5500CCG
- GSK Investigational Site
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Tucuman、アルゼンチン、4000
- GSK Investigational Site
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Buenos Aires
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Mar del Plata、Buenos Aires、アルゼンチン、B7600FZN
- GSK Investigational Site
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London、イギリス、E1 2AT
- GSK Investigational Site
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London、イギリス、SW3 6HP
- GSK Investigational Site
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Manchester、イギリス、M23 9LT
- GSK Investigational Site
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Southampton、イギリス、SO16 6YD
- GSK Investigational Site
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Leicestershire
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Leicester、Leicestershire、イギリス、LE3 9QP
- GSK Investigational Site
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Cherkassy、ウクライナ、18009
- GSK Investigational Site
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Dnipropetrovsk、ウクライナ、49006
- GSK Investigational Site
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Dnipropetrovsk、ウクライナ、49051
- GSK Investigational Site
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Dnipropetrovsk、ウクライナ、49027
- GSK Investigational Site
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Donetsk、ウクライナ、83003
- GSK Investigational Site
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Donetsk、ウクライナ、83099
- GSK Investigational Site
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Kharkiv、ウクライナ、61035
- GSK Investigational Site
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Kiev、ウクライナ、03680
- GSK Investigational Site
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Kyiv、ウクライナ、03038
- GSK Investigational Site
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Kyiv、ウクライナ、03115
- GSK Investigational Site
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Mykolayiv、ウクライナ、54003
- GSK Investigational Site
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New South Wales
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New Lambton、New South Wales、オーストラリア、2305
- GSK Investigational Site
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- GSK Investigational Site
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Victoria
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Clayton、Victoria、オーストラリア、3168
- GSK Investigational Site
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Melbourne、Victoria、オーストラリア、3004
- GSK Investigational Site
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
- GSK Investigational Site
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Alberta
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Calgary、Alberta、カナダ、T2N 4Z6
- GSK Investigational Site
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z 1M9
- GSK Investigational Site
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Ontario
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Mississauga、Ontario、カナダ、L5A 3V4
- GSK Investigational Site
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Mississauga、Ontario、カナダ、L5M 2V8
- GSK Investigational Site
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Quebec
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Quebec City、Quebec、カナダ、G1V 4G5
- GSK Investigational Site
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Santiago、チリ、8380453
- GSK Investigational Site
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Talcahuano、チリ、4270918
- GSK Investigational Site
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Región Metro De Santiago
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Puente Alto - Santiago、Región Metro De Santiago、チリ、8207257
- GSK Investigational Site
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Valparaíso
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Valparaiso、Valparaíso、チリ、2341131
- GSK Investigational Site
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Berlin、ドイツ、10367
- GSK Investigational Site
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Berlin、ドイツ、10717
- GSK Investigational Site
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Berlin、ドイツ、14050
- GSK Investigational Site
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Berlin、ドイツ、12203
- GSK Investigational Site
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Brandenburg
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Ruedersdorf、Brandenburg、ドイツ、15562
- GSK Investigational Site
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Hessen
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Frankfurt、Hessen、ドイツ、60596
- GSK Investigational Site
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Frankfurt am Main、Hessen、ドイツ、60596
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、ドイツ、55131
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg、Sachsen-Anhalt、ドイツ、39112
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck、Schleswig-Holstein、ドイツ、23552
- GSK Investigational Site
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Clamart、フランス、92140
- GSK Investigational Site
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Marseille cedex 20、フランス、13915
- GSK Investigational Site
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Montpellier、フランス、34295
- GSK Investigational Site
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Nantes、フランス、44093
- GSK Investigational Site
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Saint Pierre cedex、フランス、97448
- GSK Investigational Site
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Bialystok、ポーランド、15-276
- GSK Investigational Site
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Lodz、ポーランド、90-153
- GSK Investigational Site
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Warszawa、ポーランド、01-138
- GSK Investigational Site
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Wroclaw、ポーランド、54-239
- GSK Investigational Site
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Zawadzkie、ポーランド、47-120
- GSK Investigational Site
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Zgierz、ポーランド、95-100
- GSK Investigational Site
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Bucharest、ルーマニア、050159
- GSK Investigational Site
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Bucuresti、ルーマニア、70000
- GSK Investigational Site
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Iasi、ルーマニア、700115
- GSK Investigational Site
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Targu Mures、ルーマニア、540143
- GSK Investigational Site
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Barnaul、ロシア連邦、656 045
- GSK Investigational Site
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Chelyabinsk、ロシア連邦、454106
- GSK Investigational Site
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Kazan、ロシア連邦、420015
- GSK Investigational Site
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Moscow、ロシア連邦、105 077
- GSK Investigational Site
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Moscow、ロシア連邦、115478
- GSK Investigational Site
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Moscow、ロシア連邦、123 182
- GSK Investigational Site
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Saint-Petersburg、ロシア連邦、194354
- GSK Investigational Site
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St. Petersburg、ロシア連邦、198216
- GSK Investigational Site
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Tomsk、ロシア連邦、634001
- GSK Investigational Site
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Bucheon-si,、大韓民国、420-767
- GSK Investigational Site
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Cheongju, Chungcheongbuk-do、大韓民国、361-711
- GSK Investigational Site
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Seoul、大韓民国、152-703
- GSK Investigational Site
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Seoul、大韓民国、133--792
- GSK Investigational Site
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Suwon, Kyonggi-do、大韓民国、443-721
- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～65年 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or female
- Aged 12 to 65 years inclusive
- Minimum weight 45kg
- Clinical features of severe refractory asthma
- Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
- Using additional controller medication in addition to high dose ICS for at least 12 months
- Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
- Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
- History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
- Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
- ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
- Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
- Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
- Able to give written informed consent
- Able to read, comprehend and write at a sufficient level to complete study materials
Exclusion Criteria:
- Current smokers or smoking history of >=10 pack years
- Clinically important lung condition other than asthma
- Diagnosis of malignancy or in the process of investigation
- Unstable liver disease
- Churg-Strauss syndrome
- Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
- Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
- Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
- Allergy/intolerance to the excipients in the mepolizumab formulation
- Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
- Pregnant or breastfeeding or planning to become pregnant
- Clinically significant disease which is uncontrolled with standard treatment
- History of alcohol misuse or substance abuse
- Parasitic infestation within previous 6 months
- Known immunodeficiency
- Unable to follow instructions, use the electronic diary or peak flow meter
- Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
- Previous participation in a study of mepolizumab and received study medication within 90 days
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Mepolizumab 750mg
Mepolizumab 750mcg i.v.
every 4 weeks
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Mepolizumab 750mg every four weeks by i.v.
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アクティブコンパレータ：Mepolizumab 250mg
Mepolizumab 250mcg i.v.
every 4 weeks
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Mepolizumab 250mg every four weeks by i.v.
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アクティブコンパレータ：Mepolizumab 75mg
Mepolizumab 75mcg i.v.
every 4 weeks
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Mepolizumab 75mg every four weeks by i.v.
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プラセボコンパレーター：Placebo
Placebo saline every 4 weeks i.v.
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Placebo saline every four weeks by i.v.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Clinically Significant Exacerbations of Asthma Per Year
時間枠：From randomization (Week 0) to Week 52 or early withdrawal (EW)
|
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit.
The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year.
Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
|
From randomization (Week 0) to Week 52 or early withdrawal (EW)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
時間枠：From randomization (Week 0) to Week 52 or EW
|
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit.
Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
|
From randomization (Week 0) to Week 52 or EW
|
|
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
時間枠：From randomization (Week 0) to Week 52 or EW
|
The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year.
Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
|
From randomization (Week 0) to Week 52 or EW
|
|
Time to First Exacerbation Requiring Hospitalization or ED Visit
時間枠：From randomization (Week 0) to Week 52 or EW
|
Exacerbations of asthma requiring hospitalization or ED visit were assessed.
Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
|
From randomization (Week 0) to Week 52 or EW
|
|
Number of All Recorded Exacerbations Per Year
時間枠：From randomization (Week 0) to Week 52 or EW
|
Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par.
on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit.
In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex.
All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process.
Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.
|
From randomization (Week 0) to Week 52 or EW
|
|
Time to First All Recorded Exacerbation
時間枠：From randomization (Week 0) to Week 52 or EW
|
All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process.
In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation.
Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).
|
From randomization (Week 0) to Week 52 or EW
|
|
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
時間枠：From Baseline up to Week 52 or EW
|
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second.
Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit.
The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value.
Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
|
From Baseline up to Week 52 or EW
|
|
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
時間枠：From Baseline up to Week 52 or EW
|
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second.
Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52.
Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method.
Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network.
The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value.
Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment
|
From Baseline up to Week 52 or EW
|
|
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
時間枠：From Baseline up to Week 52 or EW
|
The ACQ-6 is a six-item questionnaire.
The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week.
The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale.
The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled).
Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value.
Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.
|
From Baseline up to Week 52 or EW
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.
- Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, Ortega H, Chanez P. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. [Lancet]. 2012;380(August 18, 2012):
- Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Review.
- Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.
- Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.
- Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.
- Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.
- Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.
- Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年11月1日
一次修了 (実際)
2012年3月23日
研究の完了 (実際)
2012年3月23日
試験登録日
最初に提出
2009年10月22日
QC基準を満たした最初の提出物
2009年10月22日
最初の投稿 (見積もり)
2009年10月23日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月24日
QC基準を満たした最後の更新が送信されました
2018年1月18日
最終確認日
2018年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 112997
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
試験データ・資料
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注釈付き症例報告書
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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インフォームド コンセント フォーム
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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個人参加者データセット
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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データセット仕様
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子：112997情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Mepolizumab 750の臨床試験
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Cardurion Pharmaceuticals, Inc.募集
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Cardurion Pharmaceuticals, Inc.募集心臓疾患 | 心血管疾患 | 心不全 | 駆出率が低下した心不全アメリカ