drugset / Trial / NCT07362238
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Timeline
- Start
- 2026-03
- Primary completion
- 2028-03
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | — |