Initial Treatment of Patients With Immune Thrombocytopenic Purpura

Last updated: January 2, 2014
Sponsor: HealthCore-NERI
Overall Status: Terminated

Phase

3

Condition

Idiopathic Thrombocytopenic Purpura (Itp)

Thrombocytopenic

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

N/A

Clinical Study ID

NCT00991939
675
HL072033
HL072268
HL072248
HL072191
HL072283
HL072359
HL072290
HL072331
HL072346
HL072299
U01HL072268
HL072072
HL072028
HL072289
HL072274
HL072291
HL072355
HL072305
HL072196
  • Ages > 15
  • All Genders

Study Summary

This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with prednisone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must meet criteria for a diagnosis of ITP as specified by ASH guidelines

  • Must be within 30 days after diagnosis of ITP at the time of randomization (diagnosisof ITP starts with first platelet count ≤ 100,000/μl)

  • Platelet count ≤ 30,000/μl at the time ITP is diagnosed, and/or at some time betweenthe diagnosis of ITP and study entry

  • Platelet count ≤ 150,000/μl at the time of randomization

  • Age ≥ 15 years

  • If bone marrow examination is available, it must be compatible with ITP

  • Subjects, or their legal guardians, must have the ability to provide informed consent

Exclusion

Exclusion Criteria:

  • Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8weeks.

  • Known HIV infection

  • Known HCV infection

  • Known systemic lupus erythematosus

  • Pregnancy or breastfeeding

  • Insulin-requiring diabetes mellitus

  • Previous exposure to prednisone for ITP at a dose ≥ 1.5 mg/kg prednisone/day for ≥ 1week prior to study entry

  • Ongoing use of treatments that are known to inhibit platelet function, e.g. aspirin

  • Anything that in the opinion of the investigator is likely to interfere withparticipation in the study

  • Persons previously randomized in the ITP^2 study

  • Persons currently enrolled in other interventional clinical trials

  • Exposure to thrombopoietic agent prior to study entry

  • Previous exposure to dexamethasone for the treatment of ITP at a dose of 30 mg/day orgreater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for atleast four days

Study Design

Total Participants: 8
Study Start date:
January 01, 2010
Estimated Completion Date:
March 31, 2013

Study Description

ITP is a common disorder associated with significant morbidity. For more than 40 years it has been recognized that this disorder was responsive to corticosteroid therapy. As corticosteroids are easily obtainable and inexpensive, they have become the standard first-line therapy for adult patients with newly-diagnosed ITP. Generally, patients are treated with prednisone at a dose of approximately 1 mg/kg, or 60 mg/day, and once a response is obtained the daily dosage is gradually tapered. While approximately 70% of patients treated in this manner respond initially, most will relapse as the corticosteroid dose is lowered; ultimately only 15-20% of patients achieve a complete or partial remission of their ITP at an "acceptable" dose of prednisone. Recently, several studies have suggested that the use of high dose corticosteroids, specifically pulse dexamethasone, may be a more efficacious initial therapy for ITP, capable of causing a higher initial response rate and a significantly longer duration of remission despite a shorter course of initial therapy.

This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with standard oral corticosteroids. This may reflect the ability of high dose corticosteroids to eradicate a sensitive pathogenic lymphoid clone that may be transiently susceptible to aggressive immunosuppressive therapy early in the course of disease.

Connect with a study center

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Children's Hospital Boston

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Weill Medical College, Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Presbyterian and Shadyside Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Gundersen Clinic

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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