Study of Eltrombopag in Children Aged 6 to 17 With Aplastic Anemia Not Previously Treated With Anti-Thymocyte Globulin

What this Trial Is About

Researchers are evaluating eltrombopag in pediatric patients with aplastic anemia AA who have not previously received Anti-Thymocyte Globulin ATG treatment. This observational, multicenter study aims to confirm the safety and efficacy of eltrombopag when used in this specific patient group. The study focuses on children aged 6 to under 18 years and is sponsored by Novartis Pharmaceuticals. Eltrombopag will be administered following the dosage and administration instructions in the most recent package insert. The study does not involve treatment allocation but observes patients receiving eltrombopag in routine clinical practice. Participants are monitored for up to one year 364 days from the start of eltrombopag treatment, or until hematopoietic stem cell transplantation if it occurs within that year. During the study, participants will be observed for serious adverse events, adverse drug reactions, and hematologic response. Researchers will track changes in blood counts including platelets, hemoglobin, neutrophils, and reticulocytes, as well as transfusion dependence and volume. Safety aspects such as hepatic dysfunction, hematopoietic malignancies, and clonal evolution will also be assessed. The studys primary outcome is the occurrence of serious adverse events within one year.

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