Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2025-02-01
Last updated
2025-06-08
Condition(s) studied
Sever Aplastic AnaemiaElderly (People Aged 65 or More)Immunosuppressive Treatment
Investigational drug(s) / intervention(s)
Dose-attenuated IST and Hetrombopag
Dose-attenuated IST and Hetrombopag: Porcine-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.
Study 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
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Hematologic response rate at 24 weeks post-ATG treatment. — 24 weeks PR+CR Partial Response (PR) : Independence from transfusions without meeting CR. No Response (NR) : Failure to achieve PR.
Trial sites (1)
Facility
City
Region
Status
Red Blood Cell Diseases Center
Tianjin
Tianjin Municipality
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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