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Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP

NCT07189910 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-24

No results posted yet for this study

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.

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Interventions

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).

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Heng Mei · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-11-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189910 on ClinicalTrials.gov