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NCT05891249Not yet recruiting

A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India

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 Subjects Who Have Had Unsatisfactory Response to or Are Ineligible to Erythropoietin Based Therapy and in Subjects With Transfusion Dependent Anemia Due to Beta-Thalassemia
Bristol-Myers SquibbPhase 4ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Anemia
Drug/Device/Intervention
Luspatercept
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Bristol-Myers Squibb
Timeline & enrollment
Phase
Phase 4
Start date
Jun 08, 2023
End date
Feb 17, 2026
Enrollment
60 participants
Primary outcome

β-Thal Cohort: Number of participants with treatment-related adverse events (AEs) of grade 3 or higher,MDS-Ring Sideroblasts (RS) Cohort: Number of participants with treatment-related AEs of grade 3 or higher

Summary

The purpose of this study is to evaluate the safety and effectiveness of luspatercept in
 participants who require regular blood cell transfusions due to b-thalassemia and
 myelodysplastic syndromes in India

ICD-10 classifications
Anaemia, unspecifiedOther anaemiasOther specified anaemiasIron deficiency anaemiaIron deficiency anaemia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05891249
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05891249 through Pure Global AI's free database. This Phase 4 trial is sponsored by Bristol-Myers Squibb and is currently Not yet recruiting. The study focuses on Anemia. Target enrollment is 60 participants.

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