drugset / Trial / NCT03988608

Study Assessed the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.

NCT03988608

Phase 2 Completed 20 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This was a non-randomized, open-label, phase II study to assess the efficacy and safety of eltrombopag in Chinese subjects with refractory or relapsed severe aplastic anemia (SAA). Treatment with eltrombopag was started at 25 mg/day and increased by 25 mg/day every 2 weeks according to the platelet count up to 150 mg/day. The hematological response rate was assessed at 3, 6 months and 1 year after starting the study treatment (Week 13, 26 and 52).

Timeline

Start
2019-12-09
Primary completion
2021-07-16
Completion
2023-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Eltrombopag Small molecule 25 mg

Indications