About this trial
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
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of VSAA/SAA.
Age ≥65 years.
Completion of all screening assessments.
Must be able to swallow tablets.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Dose-attenuated IST and Hetrombopag
DrugPorcine-ATG : 15 mg/kg/day IV ×5 days. Cyclosporine : 3-5 mg/kg/day (adjusted to trough 100-200 μg/L). Hetrombopag: 15 mg daily for 24weeks.
Treatment groups
Trial outcomes
Primary outcomes
Hematologic response rate at 24 weeks post-ATG treatment.
PR+CR Partial Response (PR) : Independence from transfusions without meeting CR. No Response (NR) : Failure to achieve PR.
Secondary outcomes
Early mortality rate
Early mortality rate within 12weeks
Complete Response
Complete Response (CR) : HGB ≥100 g/L, PLT ≥100×10⁹/L, ANC ≥1.0×10⁹/L.
Sponsors and contacts
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