Health Condition 1: D619- Aplastic anemia, unspecified
Conditions
Interventions
Intervention1: Romiplostim: Tab Cyclosporin A 100mg BD
Tab Mennabol 2mg TDS
Inj Rompilostim 600mcg s/c weekly
For 6months
Control Intervention1: Eltrombopag: Tab Cyclosporin A 100mg BD
Tab Mennabol 2
Sponsors
Government of Uttar Pradesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed cases of Aplastic anemia 2. Patient age >15years 3. Not willing for ASCT and ATG. 4. Non- pregnant women. 5. Those who consent to take part in the study. 6. No hepatic or renal disease. 7. No drug h/o that causes Myelo-suppression.
Exclusion criteria
Exclusion criteria: 1. Previous history of HSCT, 2. Patients eligible for HSCT 3. Patients with HIV/ HCV/ HBV infections. 4. Significant PNH clone and Myelodysplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Complete response (CR) defined as—transfusion independent, 2.Non-responders will be transfusion-dependent Timepoint: 3months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hemoglobin =11 g/dL, Absolute neutrophil count (ANC) more than 1.5 x 10 9 /L and platelet =150 x 10 9 /L; 2. Partial response (PR) will be those who are transfusion independent, hemoglobin =8 g/dL, ANC more than 0.5 x 10 9 /L and platelet =20 x 10 9 /L Timepoint: 3months and 6months | — |
Countries
India
Contacts
Public ContactMritunjay Kumar
IMS, BHU
Outcome results
None listed