At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
Prednisone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
In Brief
A Phase 3 clinical trial evaluating Prednisone and Dexamethasone for Purpura, Thrombocytopenic, Idiopathic. Completed, enrolled 26 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPurpura, Thrombocytopenic, Idiopathic
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2002
Primary CompletionJan 2015
First PostedJan 2015
TodayJul 2026
First PostedJan 8, 2015
Enrollment StartJul 1, 2002
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 12.5 yearsPosted 11.5 years ago
Interventions
Prednisonedrug
Continuous daily therapy
Dexamethasonedrug
4-day pulses every 3 weeks