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Recruiting Phase 2 NCT07010237

Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia

Trial Parameters

Condition Sever Aplastic Anaemia
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 65
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2025-02-01
Completion 2028-12-31
Interventions
Dose-attenuated IST and Hetrombopag

Brief Summary

This is a prospetive,Single-Center, Single-Arm, Phase IIB Clinical Study.This study aims to evaluate the efficacy and safety of dose-attenuated IST combined with Hetrombopag in elderly patients (≥65 years) with VSAA/SAA.

Eligibility Criteria

Inclusion Criteria: * Clinical diagnosis of VSAA/SAA. * Age ≥65 years. * Completion of all screening assessments. * Must be able to swallow tablets. * Signed informed consent (by patient or legal guardian if patient is incapacitated). Exclusion Criteria: * Clonal cytogenetic abnormalities (excluding isolated -Y or +8). * Prior treatment with ATG/high-dose cyclophosphamide. * Prior cyclosporine/tacrolimus use \>12 months. * Prior TPO-RA therapy \>3 months. * Uncontrolled malignancies or conditions contraindicating ATG. * Severe organ dysfunction (e.g., creatinine ≥177 μmol/L). * Investigator judgment of unsuitability.

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