To Evaluate Long- Term Safety and Efficacy of Luspatercept
Launched by FONDAZIONE PER LA RICERCA SULLE ANEMIE ED EMOGLOBINOPATIE IN ITALIA · Mar 10, 2025
Trial Information
Current as of April 23, 2025
Active, not recruiting
Keywords
ClinConnect 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 erythrocyte maturation. The efficacy of luspatercept was demonstrated in the phase III clinical trial called "BELIEVE." With market authorization, the drug is used in less selected patients with potentially more complex medical histories than those enrolled in the registration study. In addition, it is now also possible to prescribe the drug in patients with blood consumption at baseline between 20 and 2...
Gender
ALL
Eligibility criteria
- 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
About Fondazione Per La Ricerca Sulle Anemie Ed Emoglobinopatie In Italia
Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia is a dedicated research foundation focused on advancing the understanding and treatment of anemias and hemoglobinopathies. Committed to fostering innovation in clinical research, the foundation collaborates with healthcare professionals, academic institutions, and industry partners to facilitate groundbreaking studies aimed at improving patient outcomes. Through its initiatives, the foundation seeks to enhance awareness, support clinical trials, and promote the development of novel therapeutic approaches, ultimately striving to make significant contributions to the field of hematology in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cagliari, Italia, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported