Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia (EIS2002)
Purpura, Thrombocytopenic, Idiopathic
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
Inclusion Criteria:
- First episode of ITP
Exclusion Criteria:
- Pregnancy
- Glucocorticoid intolerance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A: daily prednisone
Arm B: pulsed dexamethasone
During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.
During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).