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 May 09, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the long-term safety and effectiveness of a medication called luspatercept for people with a serious blood disorder known as Thalassemia Major. The study focuses on individuals who are dependent on blood transfusions and have started receiving luspatercept since it became available in regular clinical practice. It's important to note that the trial is currently active, but they are not recruiting new participants at this time.
To be eligible for this trial, individuals must have received at least one dose of luspatercept after it was introduced in clinical settings. Unfortunately, those who received the medication through a special program for compassionate use, or who do not want to sign an informed consent form, cannot participate. If someone is eligible, they can expect to be monitored over time to see how well the medication works and to check for any potential side effects. This ongoing assessment will help doctors understand how luspatercept can best support patients with Thalassemia Major.
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