Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Idiopathic Thrombocytopenic Purpura

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 mo...

Eligibility Criteria

Inclusion

  • adult patients \>=18 years of age;
  • untreated ITP.

Exclusion

  • ITP with relapse;
  • positive test result for HIV or hepatitis B or C;
  • active infection requiring systemic therapy;
  • malignancy within 3 years before study.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

103 Patients enrolled

Trial Details

Trial ID

NCT00770562

Start Date

July 1 2005

End Date

July 1 2008

Last Update

October 22 2014

Active Locations (22)

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Page 1 of 6 (22 locations)

1

Bari, Italy, 70124

2

Bologna, Italy, 40138

3

Brescia, Italy, 25123

4

Cagliari, Italy, 09121