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Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)

NCT00372892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-06-07

No results posted yet for this study

Summary

The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).

Conditions

  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

Rituximab

375mg/m2 per week for 4 consecutive weeks

DRUG

Placebo

Saline IV placebo once per week for 4 consecutive weeks

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Donald M Arnold, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

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 NCT00372892 on ClinicalTrials.gov