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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Participants assigned to the observation group will be treated with eltrombopag oral suspension (EPAG-pfos).
Participants in the control group will receive a placebo at the same dose, instead of eltrombopag oral suspension (EPAG-pfos).
Wuhan Union Hospital
Wuhan, Hubei, China
Sustained response rate (SRR) at 3 months of treatment.
Sustained response rate (SRR) at 3 months of treatment.
Time frame: 3 months of the study
The proportions of patients achieving response (R);
The proportions of patients achieving response (R);
Time frame: 6 months of the study
Platelet count levels at 3 months after treatment
Platelet count levels at 3 months after treatment
Time frame: 3 months of the study
The proportions of patients achieving complete response (CR);
The proportions of patients achieving complete response (CR);
Time frame: 6 months of the study
The proportions of patients achieving and platelet counts ≥50×10⁹/L;
The proportions of patients achieving and platelet counts ≥50×10⁹/L;
Time frame: 6 months of the study
Sustained response rate (SRR) at 6 months;
Sustained response rate (SRR) at 6 months;
Time frame: 6 months of the study
Time to response (TTR);
Time to response (TTR);
Time frame: 6 months of the study
Time from treatment initiation to first achievement of PLT ≥100×10⁹/L;
Time from treatment initiation to first achievement of PLT ≥100×10⁹/L;
Time frame: 6 months of the study
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