A Phase 2/3 interventional study of High dose Dexamethasone pulses and Prednisone in ITP and Croticosteroid Therapy, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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
Therapy of Adults affected by idiopathic thrombocytopenic purpura with 3 cycles pulses of high-dose dexamethasone (HD-DXM): a prospective randomized clinical trial Alireza Sadeghi, Saeid Rezaei Jouzdani, Forough Hosseini
Introduction :
Idiopathic thrombocytopenic purpura(ITP) is an autoimmune disorder characterized by platelet destruction leading to decreased platelet count and an increased risk of bleeding. Mechanisms including autoantibody- mediated platelet destruction, cytotoxic T-lymphocyte platelet lysis, impaired platelet maturation and production has been identified in the pathogenesis of ITP.(1)The first line treatment of ITP is still corticosteroid therapy. Prednisone(PDN) is the standard corticosteroid therapy in ITP practical guideline usually given at 1 mg/kg per day for 4 weeks and then tapered.(2) Recent studies suggested pulsed high-dose dexamethasone given at a dose 40 mg/day to a 4-day course treatment as an alternative corticosteroid instead of prednisone to reduce the duration and the adverse effect of corticosteroid therapy.(3-5) A multicenter randomized clinical trial compared the 2 corticosteroid therapy and suggested that HD-DXM has more effective and better tolerance than PDN.(4) Another multicenter cohort study using repeated courses of HD-DXM (from 6 to 4 cycles, repeated each cycle 28 days to 14 days interval) confirmed the benefit as compared with conventional therapy and proposed as a first-line treatment for patients with ITP. Also there was no difference in overall response rate between the third and the fourth cycles of HD-DXM pulses therapy, using 3 therapy cycles with 14 days interval between each cycle, has been proposed for better safety and efficacy.(5) 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 ITP(6) to 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.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Patients in PDN arm received PDN
Drug: Prednisone
In HD-DXM arm, DXM was administered
Drug: High dose Dexamethasone pulses
In HD-DXM arm, DXM was administered intravenously at 40 mg in 500cc normal saline (0.9% saline) during 1 hour for consecutive 4 days and then stopped. This cycle was repeated in 14 days interval to receive 3 cycles of treatment.
Patients in PDN arm received PDN orally at 1.0 mg/kg body weight daily for 4 consecutive weeks. After achieving responses the medication tapered gradually to less than 15mg daily or terminated over 4-6 weeks aimed at maintaining platelet count over 30 ×109/L.
platelet count
Time frame: 6-12 months
Plan to share: Yes
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Isfahan University of Medical Sciences