Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone

• Status: Completed
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective, randomized, controlled clinical trial investigators' aim was to compare the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional treatment with PDN for untreated adult patients with ITP. In this study standardized criteria and definitions were used according to consensus international working group guideline for ITPto compare clinical outcomes of the two corticosteroid treatment regimens and determine the superior regimen as a first line strategy for new primary ITP in adults

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Collaborator: Adibvira
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Prednisone

Criteria

Inclusion Criteria:

• The eligible patients for this study were aged 18 or older of both genders with newly diagnosed primary ITP according to the international working group (IWG) guideline(6). All patients included in the study were treatment naïve ITP within 3 months from diagnosis and a platelet count of no more the 30×10^9/L, or more than 30×10^9/L with presence of bleeding symptoms according to the grading score of bleeding

Exclusion Criteria:

• malignancy, pregnancy or lactation, liver and kidney failure, connective tissue disorders, seropositive detection of HIV, hepatitis B virus or hepatitis C virus or any recent viral infection, active infection, diabetes, hypertension, cardiovascular disorders, autoimmune hemolytic anemia, psychosis, osteoporosis, any corticosteroid or immunosuppressive therapy in 3 months before diagnosis and any previous ITP-specific therapy.