Status:
ACTIVE_NOT_RECRUITING
To Evaluate Long- Term Safety and Efficacy of Luspatercept
Lead Sponsor:
Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
Conditions:
Thalassemia Major
Eligibility:
All Genders
18+ years
Brief Summary
An observational study to evaluate long-term safety and efficacy of luspatercept in subjects with transfusion dependent who received the first dose of luspatercept after its introduction in the clinic...
Detailed Description
Luspatercept represents the first and only erythroid maturation agent (EMA) approved by the European Commission (EC) and the Food and Drug Administration (FDA) capable of enhancing advanced erythrocyt...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects who received at least one dose of luspatercept after its introduction in the clinical practice
- Exclusion Criteria:
- Subjects who received luspatercept after participating in the "compassionate" use program
- Subjects unwilling to sign informed consent
Exclusion
Key Trial Info
Start Date :
April 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06875219
Start Date
April 30 2023
End Date
February 24 2026
Last Update
March 13 2025
Active Locations (1)
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1
UniversityCagliari, OspPed Microcitemico, Cagliari
Cagliari, Italia, Italy, 09121