drugset / Trial / NCT07345000
A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, double-blind, multicenter trial designed to evaluate treatment with romiplostim N01+ IST compared with placebo + IST in the participants with treatment-naïve severe aplastic anemia.
Timeline
- Start
- 2026-01
- Primary completion
- 2029-10
- Completion
- 2030-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim N01 | Peptide | 10 ug/kg | — |
| Comparator | Cyclosporine | Peptide | 5 mg/kg | Oral |
| Comparator | anti-human T lymphocyte porcine immunoglobulin | Protein / enzyme biologic | 25 mg/kg | — |
| Comparator | rATG | Unknown | 25 mg/kg | — |
| Comparator | rATG | Unknown | 25 mg/kg | — |