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Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia

NCT02334813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-06-09

Study results available
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Summary

Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1 between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary endpoint is duration of remission defined as platelets ≥50/nl.

Conditions

  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

Prednisone

Continuous daily therapy

DRUG

Dexamethasone

4-day pulses every 3 weeks

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Ulrich Dührsen, MD · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2015-01-31
Completion
2015-01-31

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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 NCT02334813 on ClinicalTrials.gov