clinical trial · NCT07345000
A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia
Qilu Pharmaceutical Co., Ltd.·phase3·not yet recruiting·n = 210
Treatment-naïve Severe Aplastic AnemiaRomiplostim N01Cyclosporine A (CsA)pALG/ rATGPlaceboCyclosporine A (CsA)pALG/ rATG
brief 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.
started
Jan 1, 2026
primary completion
Oct 1, 2029
completion
Aug 1, 2030
last updated
Jan 15, 2026
official title
A Randomized, Controlled, Multicenter, Double-blind Phase III Study Evaluating the Efficacy and Safety of Romiplostim N01 Combined With Standard Immunosuppressive Therapy (IST) Versus Placebo Combined With IST in Treatment-naïve Subjects With Severe Aplastic Anemia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol