Trial Information

Summary: A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

Status: No longer recruiting

Protocol Number: ML18542

Sponsor: Roche S.p.A.

Company Division: Pharmaceutical

Official Scientific 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 thrombocytopenic purpura

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. Target sample size is 103.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Idiopathic Thrombocytopenic Purpura

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Sustained response 6 months after initial treatment

Key Secondary Outcomes: 1. Initial response by day 30 after initiation of treatment; incidence of serious and life-threatening adverse events

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2005

Trial Registration Date: 10/27/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 3:17:24 PM