Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Long- Term Safety and Efficacy of Luspatercept in Subjects Who Received at Least One Dose of Luspatercept in the Compassionate Use Phase
Lead Sponsor:
Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
Conditions:
Thalassemia Major
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
One month after the publication in the Official Gazette of the Italian Republic of the AIFA determination of price and reimbursement for the treatment indication covered by the program, those who were...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Subjects who received at least one dose of luspatercept in the compassionate phase
- Exclusion Criteria:
- \- Subjects who are not willing or able to sign the informed consent.
Exclusion
Key Trial Info
Start Date :
May 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06913634
Start Date
May 30 2023
End Date
June 30 2026
Last Update
April 6 2025
Active Locations (1)
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1
University of Cagliari, Ospedale Pediatrico Microcitemico, via Jenner sn, 09121 Cagliari -
Cagliari, CA, Italy, 09121