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中等度から重度のクローン病(CD)の小児および10代の若者を対象としたベドリズマブの研究

基本情報

NCT ID
NCT04779320
ステータス
募集中
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
120
治験依頼者名
Takeda

概要

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

対象疾患

Crohn's Disease (CD)

介入

Vedolizumab IV(DRUG)

依頼者(Sponsor)

実施施設 (4)

久留米大学病院

Kurume-Shi, Hukuoka, Japan(RECRUITING)

国立研究開発法人国立成育医療研究センター

Setagaya-Ku, Tokyo, Japan(RECRUITING)

順天堂大学医学部附属順天堂医院

Bunkyo-Ku, Tokyo, Japan(RECRUITING)

熊本赤十字病院

Kumamoto, Kumamoto, Japan(RECRUITING)