Aplastic anemia with platelet transfusion refractoriness due to anti-platelet alloantibo
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of aplastic anemia with platelet transfusion refractoriness due to platelet-reactive antibody 2) Age 20 years and older at the time of consent 3) A document consent from the patient
Exclusion criteria
Exclusion criteria: 1) Positive test for Human immunodeficiency virus or Human T-lymphotropic virus infection 2) Positive test for Hepatitis B virus surface (HBs) antigen, HBs antibody, core (HBc) antibody or Hepatitis C virus antibody. In case of HBs antigen negative and HBs or HBc antibody positive, eligible if quantitative HBV-DNA is below detection limit 3) Severe liver or kidney dysfunction 4) Severe respiratory disease or poor control heart failure and arrhythmia 5) Significant bleeding tendency, or complication of hemophilia or other coagulation factor abnormality 6) Thrombotic thrombocytopenic purpura and other diseases in which platelet transfusions are contraindicated 7) Active infectious diseases requiring treatment 8) Malignant tumors in non-remission 9) Pregnancy or nursing, a possibility of pregnancy and pregnancy wish 10) Other conditions determined inappropriate by the responsible/sub doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (frequency and extent of adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (corrected count increment) | — |
Countries
Japan
Contacts
Kyoto University Hospital