Aplastic anemia
Conditions
Interventions
Usual dose group:After the 5-days ATG/ALG transfusion period, subjects will continue to receive usual glucocorticoid therapy equivalent to1 mg/kg/d methylprednisolone, tapring from Day 15 to Day 28.
Reduced dose group:After the 5-days ATG/ALG transfusion period, subjects will receive half-dose glucocorticoid therapy equivalent to 0.5 mg/kg/d methylprednisolone, tapring from Day 6 to Day 20.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. To meet the diagnostic criteria of severe AA or transfusion-dependent non-severe AA. 2. Age between 2-65 years; 3. Body weight >12 kg; 4. Ineligible for MSD allo-HSCT 5. Subjects have voluntarily signed an informed consent form, understanding the purpose and procedure of clinical study and voluntarily complying with the trial requirements.
Exclusion criteria
Exclusion criteria: 1. Age =65 years; 2. Myocardial infarction, uncontrolled angina, uncontrolled heart failure, uncontrolled hypertension,arteriovenous thrombosis; 3. Cocurrent endocrine disese: diabetes mellitus, hyper/hypothyroidism 4.Severe osteoporosis, necrosis of the femoral head 5.Active viral hepatitis 6. Uncontrolled active infection 7.The physical status score of the Eastern Cancer Collaboration Group (ECOG) >2 points 8.Aspartic aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal 9.Creatinine level >= 2.5 times the upper limit of normal 10. Subjects with any other condition or circumstance that would, in the opinion of the Investigator, make the subject unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serum sickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and outcomes of serum sickness of different severity;Duration of serum sickness ;Incidence of glucocorticoid-related adverse reactions;Treatment response;Survival rate; | — |
Countries
China
Contacts
Public ContactGuangsheng He
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed