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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 (ฮฒ-Thal) in India - Trial NCT05891249

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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NCT05891249
Phase 4
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT05891249
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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 (ฮฒ-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

Study Focus

Anemia

Luspatercept

Interventional

biological

Sponsor & Location

Bristol-Myers Squibb

Timeline & Enrollment

Phase 4

Jun 08, 2023

Feb 17, 2026

60 participants

Primary Outcome

ฮฒ-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, unspecified
Other anaemias
Other specified anaemias
Iron deficiency anaemia
Iron deficiency anaemia, unspecified

Data Source

ClinicalTrials.gov

NCT05891249

Non-Device Trial