Page 137 - Memoria SEHH 2022

MEMORIA ANUAL 2022 SOCIEDAD ESPAÑOLA DE
HEMATOLOGÍA Y HEMOTERAPIA
GEE
FUNDACIÓN ESPAÑOLA DE HEMATOLOGÍA Y HEMOTERAPIA
• AG348-C-017 . A phase 3 double blind, randomized, placebo controlled, multicenter, study evaluating the efficacy and safety of mitapivat in subjects with non-transfusion de- pendent alpha or beta thalassemia (ENERGIZE) . Fase 3 . Eduardo José Salido Fiérrez (Hospital Universitario Virgen de la Arrixaca, Murcia), Marta Morado Arias (Hospital Uni- versitario La Paz, Madrid) .
• AG348-C-018 . A phase 3 double blind, randomized, placebo controlled, multicenter, study evaluating the efficacy and safety of mitapivat in subjects with transfusion depen- dent alpha or beta thalassemia (ENERGIZE-T) . Fase 3 . Eduardo José Salido Fiérrez (Hos- pital Universitario Virgen de la Arrixaca, Murcia), Marta Morado Arias (Hospital Universi- tario La Paz, Madrid) .
• Study CSEG101A2301 is a phase III, multicenter, randomized, double-blind study to assess the efficacy and safety of two doses of crizanlizumab versus placebo, with or without hydro- xyurea/hydroxycarbamide therapy, in adolescent and adult sickle cell disease patients with vaso-occlusive crises . Fase 3 . Marta Morado Arias (Hospital Universitario La Paz, Madrid) .
• Efficacy and safety of M281 in adults with warm autoimmune hemolytic anemia: a multicenter, randomized, double-blind, placebo-controlled study with a long-term open- label extension . Fase 2-3 . Marta Morado Arias (Hospital Universitario La Paz, Madrid) .
• An adaptive, randomized, placebo-controlled, double-blind, multi-center study of oral FT-4202, a pyruvate kinase activator in patients with sickle cell disease . Fase 2-3 . Marta Morado Arias (Hospital Universitario La Paz, Madrid), Rafael del Orbe (Hospital Universitario de Cruces, Barakaldo) .
• Estudio en fase III, aleatorizado, abierto, con control activo, multicéntrico, para evaluar la eficacia y la seguridad de crovalimab frente a eculizumab en pacientes con hemoglo- binuria paroxística nocturna (HPN) no tratada previamente con inhibidores del comple- mento . Fase 3 . Marta Morado Arias (Hospital Universitario La Paz, Madrid) .
137