Phase 3
Completed N=103
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Source: ClinicalTrials.gov NCT00770562 ↗Enrolled (actual)
103
Serious AEs
5.5%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With a Sustained Response — 36; 63 percentage of participants — p=0.004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Sustained Response |
36; 63 | 0.004 sig |
| SECONDARY Percentage of Participants With an Initial Response |
27; 68 | 0.001 sig |
| SECONDARY Percentage of Participants With an Initial Complete Response |
23; 48 | 0.015 sig |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- untreated ITP.
Exclusion Criteria
- ITP with relapse;
- positive test result for HIV or hepatitis B or C;
- active infection requiring systemic therapy;
- malignancy within 3 years before study.
Data sourced from ClinicalTrials.gov (NCT00770562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.