At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 enrolled
Drug / intervention
rituximab +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, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura
In Brief
A Phase 3 clinical trial evaluating rituximab and Dexamethasone for Idiopathic Thrombocytopenic Purpura. Completed, enrolled 103 participants across 22 sites.
Detailed Summary
This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Thrombocytopenic Purpura
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
Primary CompletionJul 2008
First PostedOct 2008
TodayJul 2026
First PostedOct 10, 2008
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.7 years ago
Interventions
rituximabdrug
Dexamethasonedrug