At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
rituximab [MabThera/Rituxan]drug
Likely dose
rituximab [MabThera/Rituxan] 1000mgfrom 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.
An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
In Brief
A Phase 2 clinical trial evaluating rituximab [MabThera/Rituxan] for Idiopathic Thrombocytopenic Purpura. Completed, enrolled 122 participants across 12 sites.
Detailed Summary
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Thrombocytopenic Purpura
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionAug 2011
TodayJul 2026
First PostedMay 21, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.1 years ago
Interventions
rituximab [MabThera/Rituxan]drug
1000mg iv on days 1 and 15