同種幹細胞移植後の中等度および重度の慢性移植片対宿主病の小児被験者における活性、安全性および薬物動態

基本情報

NCT ID

NCT03774082

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

46

治験依頼者名

Novartis

概要

This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children, and adolescents aged ≥28 days to \<18 years old with either moderate to severe treatment-naive cGvHD or SR-cGvHD. Although 46 participants were enrolled,1 participant (enrolled in the ≥6y to \<12y age group) received study treatment beyond protocol requirements and was excluded from analyses.

対象疾患

介入

依頼者（Sponsor）