At a glance
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A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic Anemia
In Brief
A Phase 2 clinical trial evaluating Eltrombopag for Aplastic Anemia. Completed, enrolled 20 participants across 5 sites.
Detailed 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).
Study Details
Timeline
Interventions
Eltrombopag are film-coated tablets containing 25 mg of eltrombopag free acid in each tablet.