Trials / Completed
CompletedNCT00770562
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rituximab | |
| DRUG | Dexamethasone |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2008-10-10
- Last updated
- 2014-10-22
- Results posted
- 2014-10-22
Locations
22 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00770562. Inclusion in this directory is not an endorsement.