The Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is conducting a Phase 3 clinical trial to evaluate the benefit of using romiplostim plus dexamethasone versus dexamethasone alone in the treatment of primary immune thrombocytopenia. Study inclusion is open to those with sustained response to any ITP treatment and without World Health Organization grade 2 or higher bleeding, after six months from stopping treatment. The maximum time on treatment with romiplostim will be one year. Then, patients will be followed up for six additional months after stopping romiplostim. Inclusion is limited to adults over the age of 18 years, who have newly diagnosed ITP and have platelet counts less than 30,000 µL with bleeding symptoms.
Spain
Recruiting