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A Phase 4 Study to Evaluate Safety and Effectiveness of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) With Ring Sideroblasts Who Require Red Blood Cell Transfusions in Participants Who Have Had Unsatisfactory Response to or Are Ineligible to Erythropoietin Based Therapy and in Participants With Transfusion Dependent Anemia Due to Beta-Thalassemia

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Trial Profile

A Phase 4 Study to Evaluate Safety and Effectiveness of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) With Ring Sideroblasts Who Require Red Blood Cell Transfusions in Participants Who Have Had Unsatisfactory Response to or Are Ineligible to Erythropoietin Based Therapy and in Participants With Transfusion Dependent Anemia Due to Beta-Thalassemia

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 21 Apr 2025

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At a glance

  • Drugs Luspatercept (Primary)
  • Indications Beta-thalassaemia
  • Focus Adverse reactions
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 16 Apr 2025 Planned End Date changed from 13 Apr 2026 to 16 Apr 2026.
  • 16 Apr 2025 Planned primary completion date changed from 17 Feb 2026 to 16 Apr 2026.
  • 16 Apr 2025 Status changed from recruiting to active, no longer recruiting.

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