Initial Treatment of Patients With Immune Thrombocytopenic Purpura

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthCore-NERI; New England Research Institutes
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Prednisone

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