drugset / Trial / NCT07001254
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia
Phase 2
Not yet recruiting
15 enrolled
Anjali Sharathkumar
Department of Health and Human Services · collabFood and Drug Administration (FDA) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Phase II open-label interventional clinical trial aims to evaluate the efficacy of romiplostim, in patients with severe aplastic anemia (SAA), both treatment naïve and relapsed/refractory, in inducing trilineage hematopoiesis in children and young adults.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2031-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim | Peptide | — | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Background | Cyclosporine | Peptide | — | — |