The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP
Key facts
- Phase
- Phase 2/3
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shandong University
- Trial code
- NCT06913374
- Record updated
- 8 April 2025
- Original description
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.Read full original descriptionShow less
Dicycle Versus Tri-cycle High-dose Dexamethasone in Adult ITP: a Multicenter Randomized Controlled Trial
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.
Inclusion: Participant must be at least 18 years of age at the time of the screening; Participant may be male or female; Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10\^9 cells per L or had bleeding manifestations, or both.
Exclusion: Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment; Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome; Participant has a history of coagulopathy disorders other than ITP; Participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2); Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation; Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin); Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase; Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.