NCT03830749

Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura

A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Humanity & Health Medical Group Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Eltrombopag	Eltrombopag Oral Tablet 25-75 mg daily for 12 weeks plus pulsed dexamethasone

Timeline

• Start date: 2018-07-01
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2019-02-05
• Last updated: 2024-02-28

Locations

1 site across 1 country: Hong Kong