UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia

This Phase II open-label interventional clinical trial aims to evaluate the efficacy of romiplostim, in patients with severe aplastic anemia (SAA), both treatment naïve and relapsed/refractory, in inducing trilineage hematopoiesis in children and young adults.

NCT Number	NCT07001254
Lead Sponsor	Anjali Sharathkumar Collaborators: Department of Health and Human Services, Food and Drug Administration (FDA)
Conditions	Aplastic Anemia
Enrollment	15 participants
Start Date	2026-08-01
Primary Completion	2031-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-19