Aplastic anemia
Conditions
Interventions
TD-NSAA Treatment Group:Hetrombopag+ standard IST (ATG + GsA)
NTD-NSAA Treatment Group:Hetrombopag+ CsA
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, regardless of gender; Non-severe aplastic anemia diagnosed within 2.6 months: met the criteria for AA but not SAA: AA was diagnosed as pancytopenia with bone marrow (BM) cytopenia without abnormal infiltration or myelofibrosis. At least two of the following criteria were met: hemoglobin concentration (HGB) = 25% of normal but =30 mL/min (Cockcroft-Gault); 5.ECOG score <=2; 6. Voluntarily participate in this study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pancytopenia caused by other causes and bone marrow hypoproliferative diseases; 2. Karyotype analysis showed clonal cytogenetic abnormalities at the time of screening. 3. Aplastic anemia with hemolytic PNH clone; 4. Prior to enrollment, aplastic anemia patients were treated with immunosuppression (CsA duration >=4 weeks) or with immunosuppression duration =4 weeks or TPO-RA for 180/100 mmHg), severe arrhythmias (e.g., complete left bundle branch block, prolonged QT interval [Bazetts' formula], torsade de pointes, etc.), and congestive heart failure class III/IV (New York Heart Association classification) at screening; 11. Known or suspected contraindication or hypersensitivity to hatrombopag, ATG, ALG or CsA; twelve A history of a malignant solid tumor in any organ system within 5 years prior to screening, regardless of treatment, metastasis, or recurrence, except for local skin basal cell carcinoma; Subjects with previous or screening findings of hematologic neoplasms; 13. Women who are pregnant or lactating; Women of reproductive age or male subjects whose partner was a woman of reproductive age refused to use contraception while taking the drug until 28 days after the last dose; 14. Any other circumstances deemed by the investigator to preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week Overall Hematological Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-week Overall Hematological Response Rate ;12- and 24-week Complete Response Rate;12- and 24-week Partial Response Rate;Proportion of Red Blood Cell/Platelet Transfusion Dependence Detached;Time to Hematologic Response;Quality of life score;Safety; | — |
Countries
China
Contacts
Public ContactFu Rong
Tianjin Medical University General Hospital
Outcome results
None listed