Aplastic Anemia
Conditions
Interventions
Non-severe/Severe Aplastic Anemia Observation Group:None
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age = 14 days); 5. ECOG score <= 2 points; The subject and their legal guardian agree to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pancytopenia caused by other reasons and bone marrow hypoplasia diseases (such as hemolytic PNH, hypoplastic myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML], autoimmune antibody-mediated pancytopenia, etc.); 2. Those who have a history of hematopoietic stem cell transplantation; 3. Those who are known or suspected to be contraindicated or hypersensitive to the raw material of hepcitopacib ethanolamine, ATG, ALG or CsA; 4. Those who have evidence of clonal cytogenetic abnormalities during screening; 5. Those who have uncontrollable bleeding and/or infection after standard treatment during screening; 6. Those who were previously or during screening were infected with or were carriers of human immunodeficiency virus (HIV), positive for hepatitis C antibody, positive for hepatitis B surface antigen or hepatitis B core antibody, and whose HBV-DNA test indicates viral replication; 7. Those whose alanine aminotransferase (ALT), aspartate aminotransferase (AST) are higher than the upper limit of normal by 2.5 times, total bilirubin is higher than the upper limit of normal by 1.5 times, and serum creatinine is higher than the upper limit of normal by 1.5 times during screening; 8. Those who have uncontrolled hypertension, severe arrhythmia, NYHA III/IV grade congestive heart failure, unstable angina pectoris, pulmonary hypertension during screening; 9. Those who have a history of liver cirrhosis or portal hypertension; Other conditions that the investigator deems unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week Overall Hematological Response Rate;12- and 24-week Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-week Overall Hematological Response Rate;12- and 24-week Partial Response Rate;Time to Hematologic Response;Recovery time of neutrophils, hemoglobin and platelets;Safety; | — |
Countries
China
Contacts
Public ContactXuhan Zhang
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Outcome results
None listed