Aplastic anemia
Conditions
Interventions
Experimental group:Eltrombopag combined with immunosuppressive therapy (IST)
Control group:IST
Sponsors
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Written study informed consent and informed permission (if applicable) signed by the subject, parent or guardian must be obtained before study participation. 2. Signed written informed consent and informed consent (if applicable), aged >=16 years. 3. The diagnosis is SAA/VSAA. 4. Allogeneic hematopoietic stem cell transplantation (HSCT) is not suitable or HSCT is not an available treatment option (as determined by local practice or national guidelines), or the subject has rejected HSCT.
Exclusion criteria
Exclusion criteria: 1. Previous use of IST, alenzumab, high-dose cyclophosphamide (>=45 mg/kg/ day) containing any ATG/ALG, or previous use of a thrombopoietin receptor agonist. 2. Known to be serologically positive for HIV. 3. Symptomatic paroxysmal nocturnal hemoglobinuria (PNH) and/or >50% PNH clones on polymorphonuclear neutrophils (PMNS) or RBC at enrollment. 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN). 5. Creatinine >=2.5 times the upper limit of normal (ULN). 6. Positive HBV DNA test for hepatitis B virus. 7. Participating in other studies at the same time or deemed unsuitable for inclusion by the researcher. 8. Any clinical history of hepatitis C infection or chronic hepatitis B infection; Or any evidence of active hepatitis at the time of subject screening. Laboratory tests show a positive serology for hepatitis C or hepatitis B (HB), defined as a positive HBsAg test. In addition, if HBsAg negative but HBcAb positive (regardless of HBsAb status), an HB DNA test will be performed, and if positive, the subject will be excluded. 9. Cardiac disease (Class II/III/IV on the modified ROSS scale for Pediatric heart failure) should not be included;Cardiac arrhythmias at risk for thrombosis (e.g., atrial fibrillation), pulmonary hypertension, or uncontrolled hypertension (>180/100 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematology;Bone marrow routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical biochemistry; | — |
Countries
China
Contacts
Public ContactDeng Shu
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Outcome results
None listed