Trials / Active Not Recruiting
Active Not RecruitingNCT05891249
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 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 Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Luspatercept | Specified dose on specified days |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2028-12-16
- Completion
- 2028-12-16
- First posted
- 2023-06-06
- Last updated
- 2025-10-20
Locations
9 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05891249. Inclusion in this directory is not an endorsement.