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Study on the Short-term Efficacy and Safety of Recombinant Human Thrombopoietin Combined With Immunosuppressant Sequential Eltrombopag Ethanolamine Dry Suspension in the Treatment of SAA/TD-NSAA

NCT07001397 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-03

No results posted yet for this study

Summary

The study included adult patients ≥18 years old with SAA and TD-NSAA who had no HLA-matched sibling donors or were not suitable for first-line allogeneic hematopoietic stem cell transplantation due to age, complications, patient wishes, etc. After admission, they were treated with standard IST combined with rhTPO for at least 28 days. After discharge, the sequential treatment of EPAG-PFOS (with an initial dose of 150mg/d) was continued for 2 months (8 weeks), and the follow-up was conducted until the 6th month (24 weeks). It was compared with the historical cohort previously treated with IST combined with EPAG to explore the short-term efficacy and safety of this treatment regimen.

Conditions

  • Aplastic Anemias

Interventions

DRUG

EPAG-pfos

The initial dose of EPAG-pfos is 150mg/d orally. The dose is adjusted according to hematological indicators, with a maximum dose of 150mg/d until hematological remission is achieved

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2026-03-23
Completion
2027-03-23

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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 NCT07001397 on ClinicalTrials.gov