Severe hepatitis-associated aplastic anaemia in children
Conditions
Interventions
Avatrombopag+IST: Avatrombopag
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 of children's HAAA refer to the 2014 Recommendations for Diagnosis and Treatment of Children's Acquired Aplastic Anemia [9], 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) [10] 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. It can ensure long-term follow-up in the diagnosis and treatment center; 8. 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. Patients with liver failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate;overall response rate;overall response rate; | — |
Countries
china
Contacts
Public Contactjie ma
Capital Medical University, National Center for Children’s Health
Outcome results
None listed