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Brief Title: 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
Official Title: 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
Study ID: NCT05891249
Brief 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0001, New Delhi, Delhi, India
Local Institution - 0011, New Delhi, Delhi, India
Vedanta Institute Of Medical Sciences, Ahmedabad, Gujarat, India
Local Institution - 0012, Bengaluru, Karnataka, India
Local Institution - 0014, Noida, Uttar Pradesh, India
Nilratan Sirkar Medical College and Hospital, Kolkatta, West Bangal, India
Gauhati Medical College and Hospital, Assam, , India
HealthCare Global Enterprises Ltd. Hospital, Bangalore, , India
Post Graduate Institute of Medical Education and Research, Chandigarh, , India
Rajiv Gandhi Cancer Institute And Research Centre, Delhi, , India
Local Institution - 0006, Hyderabad, , India
Local Institution - 0009, Kolkata, , India
KEM Hospital and Seth G S Medical College, Mumbai, , India
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR