drugset / Trial / NCT06613880
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Phase 2
Recruiting
48 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Qilu Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.
Timeline
- Start
- 2024-10-24
- Primary completion
- 2026-01-31
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim N01 | Peptide | — | — |
| Background | Cyclosporine | Peptide | — | — |
| Background | anti-human T lymphocyte porcine immunoglobulin | Protein / enzyme biologic | — | — |