drugset / Trial / NCT02334813

Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia

NCT02334813 ↗

Phase 3 Completed 26 enrolled University Hospital, Essen
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1 between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary endpoint is duration of remission defined as platelets ≥50/nl.

Timeline

Start
2002-07
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.6 mg/kg —
Comparator Prednisone Other / unclassified 1 mg/kg —
Comparator Prednisone Other / unclassified 2 mg/kg —