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The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

NCT00909077 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2019-09-10

No results posted yet for this study

Summary

In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses.

The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

Dexamethasone

Dexamethasone tablets: 40 mg/day for four days

DRUG

Dexamethasone and Rituximab

Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m\^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Hans C Hasselbalch, MD · Copenhagen University Hospital Herlev, Department of Haematology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2012-06-01
Completion
2017-08-01

Countries

  • Denmark

Study Locations

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Entities

Drugs

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 NCT00909077 on ClinicalTrials.gov