drugset / Trial / NCT06992128
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
Phase 2
Recruiting
129 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Affiliated Hospital of Nantong University · collabAffiliated Hospital of North Sichuan Medical College · collabBaoding First Central Hospital · collabChangzhi Medical College · collabNorth China University of Science and Technology · collabShenzhen Second People's Hospital · collabThe Affiliated Hospital of Qingdao University · collabThe First Affiliated Hospital of Bengbu Medical University · collabThe Second Affiliated Hospital of Dalian Medical University · collabTianjin Hospital of ITCWM-Nankai Hospital · collabWeifang People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).
Timeline
- Start
- 2025-05-22
- Primary completion
- 2028-01-31
- Completion
- 2028-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Romiplostim N01 | Peptide | 3 ug/kg | Subcutaneous |