NCT07189910

Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP

Efficacy and Safety of Glucocorticoids Combined With Recombinant Human Thrombopoietin (rhTPO) Sequential Eltrombopag Olamine for Severe Primary Immune Thrombocytopenia (ITP) in Adults

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To address the clinical need for improving early response rates, maintaining sustained responses, reducing relapse rates, and minimizing adverse events in the treatment of immune thrombocytopenia (ITP), the investigators developed a comprehensive in-hospital and post-discharge management strategy. In this study, hospitalized participants will receive a 14-day regimen of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), followed by a 10-week course of oral eltrombopag olamine dry suspension after discharge. The investigators aim to evaluate the efficacy and safety of this sequential treatment strategy in adult ITP patients.

Detailed description

To address the clinical need for improving early response rates, maintaining sustained responses, reducing relapse rates, and minimizing adverse events in the treatment of immune thrombocytopenia (ITP), the investigators developed a comprehensive in-hospital and post-discharge management strategy. This approach is based on the superior early response achieved with recombinant human thrombopoietin (rhTPO) combined with high-dose dexamethasone (HD-DXM), and the favorable efficacy of eltrombopag in maintaining long-term responses and reducing relapse. In this study, hospitalized participants will receive a 14-day regimen of HD-DXM plus rhTPO, followed by a 10-week course of oral eltrombopag olamine dry suspension after discharge. The investigators aim to evaluate the efficacy and safety of this sequential treatment strategy in adult ITP participants, with the goal of enhancing early response, sustaining remission, reducing relapse, and minimizing adverse effects. This study is expected to provide evidence-based support for optimizing ITP treatment.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Eltrombopag	Participants assigned to the observation group will be treated with eltrombopag oral suspension (EPAG-pfos).
OTHER	Placebo	Participants in the control group will receive a placebo at the same dose, instead of eltrombopag oral suspension (EPAG-pfos).

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-11-01
• Completion: 2027-12-31
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: China