[Translation] A Phase 3, Open-label, Randomized Study Comparing the Efficacy and Safety of Rotecept (ACE-536) versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naïve Subjects with Very Low, Lower, or Intermediate Risk Revised International Prognostic Scoring System (IPSS-R) Myelodysplastic Syndrome (MDS) Non-Transfusion Dependent (NTD) Anemia: The “ELEMENT-MDS” Study
主要目的:比较罗特西普与阿法依泊汀组中较低危 NTD MDS 受试者转化为TD ( ≥3 个 单位 RBC/16 周,基于 IWG 2018)的比例
次要目的:比较罗特西普与阿法依泊汀在较低 危 NTD MDS ( 基 于 IWG 2018)受试者中的红系缓解
[Translation] Primary objective: Compare the proportion of lower-risk NTD MDS subjects who convert to TD (≥3 units of RBC/16 weeks, based on IWG 2018) in the rotecept and epoetin alfa groups
Secondary objective: Compare erythroid remission in lower-risk NTD MDS subjects (based on IWG 2018) in the rotecept and epoetin alfa groups