NCT07476846

rhTPO Dose Escalation vs Eltrombopag Switch in ITP

Drug Switching Strategy Study After rhTPO Second-Line Treatment Failure in ITP: A Randomized Controlled Trial Comparing High-Dose rhTPO Versus Eltrombopag

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU/kg/d) after 14 days of treatment (PLT \< 30×10⁹/L). After a 2-week washout period, they will be randomized to the rhTPO double-dose group (Group A) and EPAG-pfos group (Group B), with blood routine monitored weekly and doses adjusted according to platelet levels, comparing the response rates of the two groups at 6 weeks after switching treatment.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Recombinant Human Thrombopoietin（rhTPO）	rhTPO (Shenyang Sunshine Pharmaceutical Co., Ltd., National Medical Product Approval No. S20050048, specification 15000U/ml), starting dose 600 IU/kg/d, continuous subcutaneous injection, blood routine monitored weekly, dose adjusted according to platelet levels.
DRUG	Eltrombopag PfOS	EPAG-PFOS (Shenyang Sunshine Pharmaceutical Co., Ltd.; 25 mg, calculated as C₂₅H₂₂N₄O₄) * Drug-Food Interactions: Administer at least 2 hours before or 4 hours after antacids, dairy products, or cationic mineral supplements. * Dosing: Initiate at 50 mg once daily; adjust the dose in 25 mg increments (not to exceed 75 mg/day) or modify dosing frequency every 2 weeks based on platelet count.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2026-03-17
• Last updated: 2026-03-17