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A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
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.
Details
| Lead sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2024-12 |
| Completion | 2025-07 |
Conditions
- Acute Graft-Versus-Host Disease
Interventions
- Jaktinib Hydrochloride Tablets
Primary outcomes
- Overall Response Rate (ORR) at Day 28 — Day 28
Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
Countries
China