グレードII-IVの急性移植片対宿主病の小児患者におけるルキソリチニブの薬物動態、活性および安全性の研究

基本情報

NCT ID

NCT03491215

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

45

治験依頼者名

Novartis

概要

The study was an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to \<18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. The trial design included four age groups: Group 1 included patients ≥12y to \<18y, Group 2 included patients ≥6y to \<12y, Group 3 included patients ≥2y to \<6y, and Group 4 included patients ≥28days to \<2y.

対象疾患

介入

依頼者（Sponsor）