Clinical Trial: A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombo
Brief 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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Percentage of Participants With a Sustained Response [ Time Frame: Week 24 ]
Original Primary Outcome: Sustained response 6 months after initial treatment
Current Secondary Outcome:
- Percentage of Participants With an Initial Response [ Time Frame: Week 4 ]Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.
- Percentage of Participants With an Initial Complete Response [ Time Frame: Week 4 ]Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.
Original Secondary Outcome: Initial response by day 30 after initiation of treatment; incidence of serious and life-threatening adverse events
Information By: Hoffmann-La Roche
Dates:
Date Received: October 9, 2008
Date Started: July 2005
Date Completion:
Last Updated: October 21, 2014
Last Verified: October 2014