Status and phase
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About
This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.
Enrollment
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Inclusion criteria
Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects who Corticosteroid dependence(ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
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Central trial contact
Yongping Song, PhD
Data sourced from clinicaltrials.gov
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