Overview

This study was a single-arm, multicenter, phase Π clinical study. Patients admitted to the enrollment unit center with a confirmed diagnosis of TDNSAA/VSAA/SAA, treated with IST (p/r-ATG+CSA) in combination with TPO-RA (including eltrombopta or hydtrombopta) for at least 3 months with no hematologic response at 6-month follow-up, and who were not suitable or unwilling to undergo hematopoietic stem cell transplantation (HSCT), were to another novel TPO-RA avatrombopta, 40-60 mg (weight <80 kg), in addition to maintaining the original immunosuppressive therapy ( CSA or equivalent immune potency drugs), switch to another new TPO-RA avatropa 40-60 mg (40 mg daily for weight <80 kg; 60 mg daily for weight >80 kg) orally once daily for at least 3 months and follow up for 3 months to determine the hematologic response and to assess the safety of the drug

Eligibility

Inclusion Criteria: Subjects eligible for inclusion in this study must meet all of the

following criteria:

1. Patients with confirmed TDNSAA/SAA/VSAA aplastic anemia who received standard IST therapy for at least 6 months, combined with Haitrombopag (15mg/d) or Eltrombopag (>50mg/d) for at least 3 Patients who have not obtained a hematological response (NR) for months and are not suitable or unwilling to undergo HSCT
2. Age > 14 years old, male or female.
3. Subjects must complete all screening assessments listed in the trial protocol.
4. ECOG score ≤ 2 points.
5. Before the start of the research procedure, the patient or guardian should fully understand the research procedure and purpose and sign the informed consent form. If the patient's signature is not conducive to the treatment of the disease, the patient's immediate family should sign the informed consent form.

        Exclusion Criteria: Subjects meeting any of the following criteria were excluded from this
        study:
          1. Patients with severe infectious diseases (uncured tuberculosis, pulmonary
             aspergillosis, various bacterial and viral infections) and active bleeding that cannot
             be controlled after standard treatment.
          2. Patients with AIDS, active viral hepatitis B, and hepatitis C RNA nucleic acid test
             positive.
          3. Those who are pregnant or breastfeeding, have fertility but are unwilling to take
             effective contraceptive measures.
          4. Congenital hematopoietic failure diseases (such as Fanconi anemia).
          5. Patients with cytogenetic clonal changes (excluding germline mutations and acquired
             chromosome clones of +8, 20q- and -y).
          6. Combined with malignant tumor within 3 years.
          7. Combined with other systemic diseases that cannot be controlled.
          8. Significant abnormalities in cardiopulmonary function.
          9. Abnormal liver and kidney function: creatinine level > 1.5 times the upper limit of
             normal, transaminase and bilirubin level > 2 times the upper limit of normal, and
             those who cannot be enrolled in the group as judged by the clinician.
         10. Those who are considered unsuitable for enrollment by the investigator.