Tebapivat for Anemia in Lower-Risk Myelodysplastic Syndromes

Tebapivat

Tebapivat

Tebapivat

Tebapivat

Phase 2a: Proportion of Participants With Hemoglobin (Hb) Response

Phase 2a: Proportion of Participants With Transfusion Independence During the Core Period

Phase 2b: Proportion of Participants With Transfusion Independence

Phase 2a: Proportion of Participants With ≥1.5-g/dL increase From Baseline in the Hb Concentration at ≥2 Consecutive Time Points From Week 8 through Week 16

Phase 2a: Change from Baseline in Total Transfused Red Blood Cell (RBC) Units During the Core Period

Phase 2a: Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation During the Core Period

Phase 2a: Proportion of Participants With Laboratory Abnormalities During the Core Period

Phase 2a: Proportion of Participants With Hb 1.0+ Response

Phase 2a: Change From Baseline in Hb Concentration During the Core Period

Phase 2a: Proportion of Participants With ≥50% Reduction in Total Transfused RBC Units for ≥8 Consecutive Weeks During the Core Period Compared With Baseline

Phase 2a: Plasma Concentration of Tebapivat During the Core Period

Phase 2a: Maximum (Peak) Concentration (Cmax) of Tebapivat During the Core Period

Phase 2a: Time to Cmax (tmax) of Tebapivat During the Core Period

Phase 2a: Area Under the Concentration-time Curve From 0 to t Hours (AUC0-t) of Tebapivat During the Core Period

Phase 2a: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval (AUC0-τ) of Tebapivat During the Core Period

Phase 2a: Apparent Terminal Elimination Half-life (t½) of Tebapivat During the Core Period

Phase 2a: Whole Blood Concentrations of 2,3-diphosphoglycerate (2,3-DPG) During the Core Period

Phase 2a: Whole Blood Concentrations of Adenosine Triphosphate (ATP) During the Core Period

Phase 2b: Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation During the Core Period

Phase 2b: Proportion of Participants With Laboratory Abnormalities During the Core Period

Phase 2b: Change From Baseline in Hb Concentration During the Core Period

Phase 2b: Change From Baseline in Total Transfused RBC Units From Week 8 Through Week 24

Phase 2b: Proportion of Participants With ≥50% Reduction in Total Transfused RBC Units for ≥8 Consecutive Weeks During the Core Period Compared With Baseline

Phase 2b: Time to First TI8 During the Core Period

Phase 2b: Proportion of Participants Who Become Transfusion-free for ≥12 Consecutive Weeks (TI12) During the Core Period

Phase 2b: Proportion of Participants With ≥50% Reduction in Total Transfused RBC Units for ≥12 Consecutive Weeks During the Core Period Compared With Baseline

Phase 2b: Time to First TI12 During the Core Period

Phase 2b: Duration of Transfusion Independence (TI)

Phase 2b: Plasma Concentration of Tebapivat During the Core Period

Phase 2b: Maximum (Peak) Concentration (Cmax) of Tebapivat During the Core Period

Phase 2b: Time to Cmax (tmax) of Tebapivat During the Core Period

Phase 2b: Area Under the Concentration-time Curve From 0 to t Hours (AUC0-t) of Tebapivat During the Core Period

Phase 2b: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval (AUC0-τ) of Tebapivat During the Core Period

Phase 2b: Apparent Terminal Elimination Half-life (t½) of Tebapivat During the Core Period

Phase 2b: Whole Blood Concentrations of 2,3-diphosphoglycerate (2,3-DPG) During the Core Period

Phase 2b: Whole Blood Concentrations of Adenosine Triphosphate (ATP) During the Core Period