Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura
Status:
Suspended
Trial end date:
2023-03-31
Target enrollment:
Participant gender:
Summary
Current first line treatments for immune thrombocytopenia (ITP) usually have transient
effects and prolonged platelet response rate off therapy remains low. The aim is to evaluate
whether a 12-week course of eltrombopag plus pulsed dexamethasone as first line therapy can
increase the proportion of patients with prolonged response. Diagnosis of ITP is established
according to the American Society of Hematology guidelines. Eligible ITP subjects have
platelet counts <30×109/L or counts <50×109/L and significant bleeding symptoms (WHO bleeding
scale 2 or above). Subjects must have no prior ITP treatment except platelet transfusions.
Treatment consists of eltrombopag 25-75 mg daily according to platelet response for 12 weeks
plus pulsed dexamethasone, 40 mg daily for 4 consecutive days every 4 weeks for 1-3 courses.
The primary endpoint is prolonged response rate which was defined as the proportion of
enrolled subjects maintaining platelet counts >50×109/L for more than 6 months without any
ITP therapy after completion of 12-week therapy.