Initial Treatment of Patients With Immune Thrombocytopenic Purpura
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Dexamethasone USP Micronized; Prednisone
Intervention description: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.; Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Intervention MeSH terms: Dexamethasone; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Immune thrombocytopenic purpura; ITP; Dexamethasone; Prednisone

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 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 (diagnosis
             of 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 between
             the 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 Criteria:

          -  Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8
             weeks.

          -  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 ≥ 1
             week 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 with
             participation 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 or
             greater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for at
             least four days