Trial Information

Summary: A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

Status: Recruiting

Protocol Number: ML20948

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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.

Brief 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. Target sample size is 106.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Idiopathic Thrombocytopenic Purpura

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: 1. Overall response rate Time frame: Week 8

Key Secondary Outcomes: 1. Time to CR and PR; CR and PR rates; duration of response; time to new therapy. Time frame: Event driven 2. AEs, hematological toxicity, infections, infusion reactions. Time frame: Throughout study

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
  • stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

  • newly diagnosed ITP (<6 weeks);
  • prior treatment with MabThera;
  • active bleeding requiring platelet transfusion within 7 days prior to entry into study.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2007

Trial Registration Date: 05/17/2007

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Westmead, Australia, 2145
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:35:00 PM


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