NCT06073860

A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 104 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

Summary

The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.

Conditions

• Myelodysplastic Syndrome
• Beta Thalassemia

Interventions

Type	Name	Description
DRUG	Luspatercept	According to the approved label

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-12-21
• Completion: 2027-12-21
• First posted: 2023-10-10
• Last updated: 2024-11-06

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study