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Rituximab as Second Line Treatment for ITP

NCT00344149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2014-03-26

No results posted yet for this study

Summary

Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia.

Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.

Conditions

  • Immune Thrombocytopenia (ITP)

Interventions

DRUG

Rituximab (Mabthera)

I.V infusion of Rituximab 375 mg/m2 per week for 4 weeks

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • South-Eastern Regional Health Authority

    collaborator UNKNOWN

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Waleed Ghanima, MD · Østfold Hospital trust in Fredrikstad

  • Pål Andre Holme · Oslo University Hospital

  • Finn Wisløff, MD, PhD · Ullevaal University Hospital

  • Anders Waage, MD, PhD · St. Olavs Hospital, Trondheim, Norway

  • Geir Tjønnfjord, MD, PhD · Rikshospitalet- Oslo-Norway

  • Peter Meyer, MD, PhD · Rogaland sentralt sykehus - Stavanger-Norway

  • Marc Michel, MD · Dept. of Internal medicine Henri Mondor University Hospital Créteil- France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Norway

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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 NCT00344149 on ClinicalTrials.gov