severe aplastic anemia in children
Conditions
Interventions
Herombopag Olamine+IST:Herombopag Olamine
control:IST
Sponsors
Capital Medical University, National Center for Children’s Health
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria for children's AA refer to the 2014 Recommendations for Diagnosis and Treatment of Children's Acquired Aplastic Anemia, excluding congenital bone marrow failure diseases, paroxysmal nocturnal hemoglobinuria, malignant tumors, etc; Patients meeting the AA diagnostic criteria were classified according to the Diagnostic and Treatment Specifications for Children's Aplastic Anemia (2019 Edition) and selected as SAA patients. 2. Age 2-18 years before treatment (2 years = 18 years); 3. All children had no compatible sibling donors and no severe organ dysfunction; 4. Have not used ATG treatment in the past; 5. First diagnosed patients; 6. No contraindication of drug treatment; 7. No severe infection; 8. It can ensure long-term follow-up in the diagnosis and treatment center; 9. Obtain the consent of the child or/and guardian, and sign on the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Life threatening bleeding at the time of enrollment; 2. Any concomitant disease or mental disease with significant abnormality, which affects the patient's life safety and compliance, and affects informed consent, research participation, follow-up or interpretation of results; 3. The children or guardians cannot follow up and their compliance is poor; 4. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis, viral infection, hepatitis B/C virus active period, for patients with positive hepatitis B B surface antigen and core antigen, those with positive perfect hepatitis B B DNA nucleic acid test will be excluded, and those with negative perfect hepatitis C RNA nucleic acid test will still be included in this clinical trial; those with positive perfect hepatitis C RNA nucleic acid test will be excluded); 5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3 times the upper limit of normal (ULN); 6. Previously used ATG/ALG, or used thrombopoietin receptor agonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;complete response rate;overall response rate; | — |
Countries
China
Contacts
Public Contactjie ma
Capital Medical University, National Center for Children’s Health
Outcome results
None listed