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Study of the Effectiveness of Rituximab in Adults With Chronic and Severe Immune Thrombocytopenic Purpura and Candidate for a Splenectomy

NCT00225875 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2005-10-27

No results posted yet for this study

Summary

The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (\>=6 months of evolution) and severe (platelets \<= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a treatment by the rituximab a satisfactory response to one year, defined by a number of platelets higher than 50x109/L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment.

Conditions

  • Autoimmune Thrombocytopenic Purpura

Interventions

DRUG

Mabthéra

Sponsors & Collaborators

  • Etablissement Français du Sang

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bertrand Godeau, Professor · Henri Mondor University Hospital

  • Philippe Bierling, Professor · EFS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2007-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225875 on ClinicalTrials.gov